[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
EVALUATING THE PAPERWORK REDUCTION ACT PART II: ARE BURDENS BEING
REDUCED?
=======================================================================
HEARING
before the
COMMITTEE ON SMALL BUSINESS
UNITED STATES
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
FIRST SESSION
__________
HEARING HELD
OCTOBER 11, 2017
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Small Business Committee Document Number 115-039
Available via the GPO Website: www.fdsys.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
27-068 PDF WASHINGTON : 2018
____________________________________________________________________
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HOUSE COMMITTEE ON SMALL BUSINESS
STEVE CHABOT, Ohio, Chairman
STEVE KING, Iowa
BLAINE LUETKEMEYER, Missouri
DAVE BRAT, Virginia
AUMUA AMATA COLEMAN RADEWAGEN, American Samoa
STEVE KNIGHT, California
TRENT KELLY, Mississippi
ROD BLUM, Iowa
JAMES COMER, Kentucky
JENNIFFER GONZALEZ-COLON, Puerto Rico
DON BACON, Nebraska
BRIAN FITZPATRICK, Pennsylvania
ROGER MARSHALL, Kansas
RALPH NORMAN, South Carolina
NYDIA VELAZQUEZ, New York, Ranking Member
DWIGHT EVANS, Pennsylvania
STEPHANIE MURPHY, Florida
AL LAWSON, JR., Florida
YVETTE CLARK, New York
JUDY CHU, California
ALMA ADAMS, North Carolina
ADRIANO ESPAILLAT, New York
BRAD SCHNEIDER, Illinois
VACANT
Kevin Fitzpatrick, Majority Staff Director
Jan Oliver, Majority Deputy Staff Director and Chief Counsel
Adam Minehardt, Staff Director
C O N T E N T S
OPENING STATEMENTS
Page
Hon. Steve Chabot................................................ 1
Hon. Nydia Velazquez............................................. 2
WITNESSES
Steven Fine, Ph.D., Acting Assistant Administrator, Acting Chief
Information Officer, United States Environmental Protection
Agency, Washington, DC......................................... 4
Mr. Stephen D. Guertin, Deputy Director for Policy, United States
Fish and Wildlife Service, Washington, DC...................... 6
Mr. Gundeep Ahluwalia, Chief Information Officer, United States
Department of Labor, Washington, DC............................ 7
Mr. Todd Simpson, Chief Information Officer, United States Food
and Drug Administration, Silver Spring, MD..................... 9
APPENDIX
Prepared Statements:
Steven Fine, Ph.D., Acting Assistant Administrator, Acting
Chief Information Officer, United States Environmental
Protection Agency, Washington, DC.......................... 21
Mr. Stephen D. Guertin, Deputy Director for Policy, United
States Fish and Wildlife Service, Washington, DC........... 24
Mr. Gundeep Ahluwalia, Chief Information Officer, United
States Department of Labor, Washington, DC................. 29
Mr. Todd Simpson, Chief Information Officer, United States
Food and Drug Administration, Silver Spring, MD............ 34
Questions and Answers for the Record:
Questions from Hon. Chabot, Hon. Kelly, Hon. Bacon, Hon.
Norman, Hon. Blum, and Hon. Knight to Steven Fine and
Answers from Steven Fine................................... 41
Questions from Hon. Chabot, Hon. Kelly, Hon. Bacon, Hon.
Norman, Hon. Blum, and Hon. Knight to Mr. Stephen D.
Guertin and Answers from Mr. Stephen D. Guertin............ 61
Questions from Hon. Chabot, Hon. Kelly, Hon. Bacon, Hon.
Norman, Hon. Blum, and Hon. Knight to Mr. Gundeep Ahluwalia
and Answers from Mr. Gundeep Ahluwalia..................... 68
Questions from Hon. Chabot, Hon. Kelly, Hon. Bacon, Hon.
Norman, Hon. Blum, and Hon. Knight to Mr. Todd Simpson and
Answers from Mr. Todd Simpson.............................. 75
Additional Material for the Record:
None.
EVALUATING THE PAPERWORK REDUCTION ACT PART II: ARE BURDENS BEING
REDUCED?
----------
WEDNESDAY, OCTOBER 11, 2017
House of Representatives,
Committee on Small Business,
Washington, DC.
The Committee met, pursuant to call, at 11:00 a.m., in Room
2360, Rayburn House Office Building, Hon. Steve Chabot
[chairman of the Committee] presiding.
Present: Representatives Chabot, Brat, Radewagen, Kelly,
Blum, Bacon, Marshall, Norman, Velazquez, Evans, Clarke, and
Schneider.
Chairman CHABOT. When we get a few more members of
Congress, we will get started.
Good morning. I imagine we will have some more members
shortly. The important ones are here. And we appreciate
everyone for being here.
This past March, the Committee on Small Business held a
hearing on the Paperwork Reduction Act, or PRA, to examine how
Federal paperwork requirements continue to be a burden for
small businesses. Even though the PRA is supposed to reduce
paperwork burdens, small businesses are still faced with an
overwhelming amount of paperwork requirements each day. In
fact, paperwork requirements are costing America almost $120
billion a year.
But as we heard at our hearing last March, this number is
probably much higher because Federal agencies may not be
accurately estimating the burden. Yes, agencies need data and
information to run their programs, but as with all things in
life, it must be in moderation.
The need for this information must be balanced against the
burden imposed to comply with these collection efforts,
especially the burden imposed on small businesses, our Nation's
job creators.
As our hearing in March demonstrated, Federal paperwork
requirements come in many different forms, no pun intended. For
example, laws such as the Clean Air Act, the National
Environmental Policy Act, and the Endangered Species Act
require small businesses to prepare lengthy permitting
applications; some applications can be thousands of pages long.
Small businesses are also subject to many different
recordkeeping and reporting requirements for numerous Federal
agencies, including the Occupational Safety and Health
Administration, the Internal Revenue Service, the Environmental
Protection Agency, and others.
Not only do small businesses have to keep piles of
paperwork and records for many years, they also have to figure
out which agency needs the information and how often. Many
times small businesses have to send the same information to
different agencies. This is a lot of paperwork.
Small businesses should be focusing their efforts on
developing, innovating, and building, on creating jobs and
growing our economy. Instead, small businesses too often are
devoting precious hours and dollars every month to filling out
forms, applications, and reports. Meanwhile, agencies issue
more and more paperwork requirements.
Today, this Committee is pivoting to hear the Federal
agency perspective. Specifically, we have four agency officials
who are responsible for ensuring that their agencies comply
with the Paperwork Reduction Act, or PRA. Under the PRA the
agency's chief information officer, or CIO, is responsible for
ensuring that the agency complies with the Act.
The CIO must determine whether collecting certain
information is necessary, how the agency plans to use the
information, and estimate what the burden will be on those who
provide the information. Only after the CIO reviews the
collection requests and certifies that it meets certain
requirements can the agency propose the collection request to
the public. In other words, the CIO and his or her team have an
important role in helping to reduce the paperwork burden on
this country's small businesses.
I want to thank all our witnesses for being here today. We
look forward to hearing your testimony about how your agency
complies with the PRA, and ways your agency reduces the
paperwork burden on small businesses.
And I would now like to yield to Ranking Member Ms.
Velazquez for her opening statement.
Ms. VELAZQUEZ. Thank you, Mr. Chairman. In 2015, the public
spent an estimated 9.78 billion hours responding to federal
information collections. While some of this information was
required as disclosures, others were for eligibility in
programs or applying for loans.
Whatever the reason, for businesses, preparing these
documents require staff, time, and money. This is felt most
acutely by small businesses who frequently lack the legal
support and resources their larger competitors have to assist
with compliance.
The Paperwork Reduction Act, or PRA, was created in 1990
and amended in 1995, with the intent of reducing the growth of
paperwork. The results have been mixed, at best. One question I
hope today's hearing can answer is whether the current law
provides agencies with the appropriate tools to address the
escalation of paperwork, or if changes must be made, for the
PRA to improve its effectiveness.
Additionally, it will be of great value to hear how
agencies strive to keep small businesses' needs in mind when
crafting regulations. As they say, the devil is in the details.
When it comes to complying with many federal reporting
requirements, small adjustments can make a difference in
reducing the burden on small firms.
While agencies face a difficult task, small businesses
deserve to know exactly why their paperwork burden continues to
grow. However, we must also remember that data collection
exists for a reason. Agencies rely on data to make informed
decisions achieving important policy outcomes.
These goals include ensuring worker safety, preserving
clean air and water, and safeguarding taxpayer dollars against
fraud. Yet the PRA should not serve to discourage agencies from
conducting proper regulatory flexibility analysis. All too
often, with the agencies implementing regulations that ignore
or understate economic impacts on small businesses, ensuring
that agencies are considering the economic impact of their
regulations and paperwork requirements on small firms is
critical.
Congress needs to know what steps are needed to help
agencies achieve this goal, whether it is embracing technology,
working to synchronize and coordinate at all levels of
government, or improving communication, it is an important
discussion we must have.
I look forward to the insights this panel will provide on
those topics. And once again, thank the witnesses for being
here today. And I yield back, Mr. Chairman. Thank you.
Chairman CHABOT. Thank you very much. The gentlelady
yields. And if members have opening statements I would ask that
they be submitted for the record.
And now I would like to take just a moment to explain our
rules and lighting system here. We operate under the 5-minute
rule. You each get 5 minutes to speak, and there is a light
system to help you. The green light will be on for 4 minutes,
the yellow light will come on and be on for about a minute to
let you know that it is about time to wrap up, and then the red
light will come on, and you are supposed to stop.
Most people do, but we will give you a little leeway there,
not a whole lot, but a little bit. And we operate, ourselves,
under the 5-minute rule, so we will restrict our time to that
as well, to be fair.
And I would now like to introduce our very distinguished
panel here today. Our first witness is Dr. Steven Fine. Dr.
Fine is the Acting Assistant Administrator of the Environmental
Protection Agency's Office of Environmental Information and
Acting Chief Information Officer. Dr. Fine joined the EPA in
2016, and before that he served at the National Oceanic and
Atmospheric Administration in different positions since 2003,
including a Deputy Assistant Administrator for Laboratories and
Cooperative Institutes, and Director of the Air Resources
Laboratory. We welcome you, Dr. Fine, and look forward to your
testimony.
Our second witness will be Stephen Guertin. Mr. Guertin is
the Deputy Director for Policy at the United States Fish and
Wildlife Service. He has been serving as the Deputy Director
since 2012. Prior to that Mr. Guertin served as the regional
director for the agency's mountain-prairie region from 2007 to
'12. He also spent 9 years working at the Department of
Interior prior to joining the Fish and Wildlife Service. Mr.
Guertin served for 8 years in the United States Marine Corps.
And we thank you very much for your service, and welcome you
here today.
Our third witness will be Mr. Gundeep Ahluwalia. I have
been practicing that since yesterday.
Mr. AHLUWALIA. You did it.
Chairman CHABOT. Thank you very much. And he has been
serving as the Chief Information Officer for the U.S.
Department of Labor since October 2016, and joined DOL as the
Deputy CIO in August of 2016. Prior to the DOL, Mr. Ahluwalia
served for 4 years as the Deputy Director of the Office of
Business Informatics at the U.S. Food and Drug Administration.
We welcome you here today, and look forward to your testimony.
And our final witness is Mr. Todd Simpson; Simpson's a fine
name, too. Mr. Simpson has been serving as the Chief
Information Officer at the U.S. Food and Drug Administration
since 2015. He has also served as the Associate CIO for the
Senior Executive Service at the Department of Transportation,
and the CIO at the Department of Justice. Mr. Simpson also
served for 6 years in the U.S. Air Force. We thank you for your
service to our country as well, and we welcome your testimony
today.
And Dr. Fine, you are recognized for 5 minutes.
STATEMENTS OF STEVEN FINE, PH.D., ACTING ASSISTANT
ADMINISTRATOR, ACTING CHIEF INFORMATION OFFICER, UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY; STEPHEN D. GUERTIN, DEPUTY
DIRECTOR FOR POLICY, UNITED STATES FISH AND WILDLIFE SERVICE;
GUNDEEP AHLUWALIA, CHIEF INFORMATION OFFICER,UNITED STATES
DEPARTMENT OF LABOR; TODD SIMPSON; CHIEF INFORMATION OFFICER,
UNITED STATES FOOD AND DRUG ADMINISTRATION
STATEMENT OF STEVEN FINE
Dr. FINE. Good morning, Chairman Chabot and Ranking Member
Velazquez. As you said, I am Steve Fine, the acting CIO for
EPA. And thank you for the opportunity to discuss EPA's
implementation of the Paperwork Reduction Act.
Congress has charged the EPA with enforcing several
statutes to protect human health in the environment. In order
to ensure the requirements of these statutes are met, the EPA
must collect information from the public. EPA has just over 400
OMB-approved collections with a total overall burden of
approximately 174 million hours.
This is approximately 1.5 percent a total Federal
Government burden. EPA collections range from over 21 million
hours for the National Pollutant Discharge Elimination System
Program, and less than 10 hours for the Mobile Air-Conditioner
Retrofitting Program.
The Agency is cognizant of the impact these collections
have on small businesses and other entities, and works to find
ways to reduce that burden while satisfying the
responsibilities assigned by statutes. The PRA mandates that
Federal agencies follow a necessarily robust process to ensure
that they are only collecting information that is needed, and
are doing so in the least burdensome way possible.
Under the PRA, the Agency must obtain approval from OMB
before using identical questions to collect information from 10
or more persons, even if responding to the request is voluntary
for the recipient. To gather information in such circumstances,
the EPA must prepare an information collection request, which
describes the information to be collected, gives the reason the
information is needed, and estimates the time and cost to the
public to answer the request.
Examples of information collections include surveys, permit
applications, questionnaires, and compliance reports. At the
EPA, subject matter experts in program offices develop ICRs.
Each program office follows the process established by EPA's
PRA office. ICRs are subject to a 6- to 10-month internal
Agency review and approval process. The Agency's PRA office
conducts an independent review of each ICR, and each ICR is
also shared with the public twice for comment via Federal
Register notices.
In addition, the Agency consults with a sample of affected
entities. Agency ICR preparers and reviewers consider factors
such as whether the collection is required to achieve the
stated environmental objective, whether there is a practical
utility to the information being collected, whether the
proposed collection method is appropriate and efficient,
whether less frequent collection of the information would be
sufficient, whether the calculation of the estimated burden is
accurate, and whether the information is collected elsewhere.
Public comments inform Agency reviews, and after Agency
reviews ICRs are sent to OMB for further review. The EPA is
sensitive to the burden it places on regulated entities, and
uses multiple approaches to reduce unnecessary reporting and
recordkeeping burdens on the public.
For example, both the program office and the PRA office
independently consider whether each part of a proposed
information collection has practical utility, is limited in
scope to only that necessary for the intended purpose, and
imposes the least burden.
Also, where feasible, the Agency obtains information from
other sources instead of the public. For example, instead of
requesting some information from coastal States, the EPA
obtains that information for the National Oceanic and
Atmospheric Administration, which collects information for its
own needs.
Additionally, the EPA is increasing using information
technologies to reduce burden by streamlining the information
collection process. For instance, this year the EPA enhanced a
Toxics Release Inventory, which is used by thousands of
facilities to describe the toxic chemical inventories, and
documents significant events, such as releases.
The enhancements of the system included new features, such
as automated data quality checks and simplified password
resetting process. These enhancements are expected to reduce
the average reporting time by 13 percent for each of the
approximately 80,000 forms submitted annually.
Another example is the new software systems that are
anticipated to reduce reporting burdens related to public water
systems by 23 percent. Further, the Agency is in the process of
developing a strategic plan covering fiscal years 2018 to 2022.
The draft plan, shared with the public for comment, includes
the strategic measure for reduction of reporting burden on the
regulated community.
This would be roughly one of two dozen measures that would
be tracked at the highest levels of the Agency. EPA remains
committed to working with small businesses and other regulated
entities to find ways to collect the information we need to
protect human health and the environment in the least
burdensome way possible.
Again, thank you for this opportunity to testify. I would
be happy to answer any questions you have.
Chairman CHABOT. Thank you very much. Mr. Guertin, you are
recognized for 5 minutes.
STATEMENT OF STEPHEN D. GUERTIN
Mr. GUERTIN. Thank you, Mr. Chairman, Ranking Member
Velazquez, and Members of the Committee. I am Steve Guertin,
deputy director for the United States Fish and Wildlife
Service. Thank you for the opportunity to testify this
afternoon.
The collection of information from the public is essential
to provide good government to the public across all sectors of
society, but information collection is a burden for the public.
Therefore, the PRA is an important tool that ensures Federal
agencies are able to collect the information needed while
making sure that they are not arbitrary in how they do it.
The PRA helps make sure we collect only the information we
need to effectively carry out our mandates while minimizing
burden on the public. The mission of the U.S. Fish and Wildlife
Service is working with others to conserve, protect, and
enhance fish, wildlife, and plants, and their habitats for the
continuing benefit of the American people. Simply put, our job
is to maintain America's wildlife heritage.
In carrying out this mission we collect information related
to a wide variety of areas, including hunting and fishing
itself, oil and gas exploration and development, import and
export of fish and wildlife products, and Federal subsistence.
This information is an important component of our analysis,
decisions, and plans. A good example to illustrate this is the
management of hunting for migratory birds. The Service
conserves bird species protected by the Migratory Bird Treaty
Act through the administration and establishment of frameworks
for annual hunting seasons and bag limits for these migratory
bird game species.
In doing so, we rely on the collection of harvest
information from migratory bird hunters, which enables us to
develop sound, science-based hunting guidelines. These harvest
surveys allow the Service to gather information on hunting
participation, success rates, and target species. We use this
and other types of information to inform our regulatory
decisions so that regulations result in sustainable hunting
guidelines that also ensure maximum hunting opportunity for the
public each year.
This year, for example, we expanded the harvest of black
ducks based on information from hunting studies and the harvest
survey program. This model for migratory bird hunting has been
a great success. Populations of migratory birds that were
declining and in danger of elimination a century ago, are now
thriving, driven by coordinated Federal and State management
informed by data collected from the public.
I would also like to really emphasize the importance of
hunting, fishing, and outdoor recreation at large. These
activities are part of the cultural fabric of America. They are
also important economic drivers that support jobs and small
businesses across the Nation. Our hunting regulations for
migratory birds and other species are a boon to local economies
in small towns up and down the major migratory flyways and
other key wildlife corridors.
To put it in perspective, in 2016, hunters, anglers, and
wildlife watchers spent more than 156 billion in their
pursuits, nearly 1 percent of the total gross national product.
A lot of this is delivered by America's small businesses. For
example, guides, outfitters, marinas, tackle shops, the people
who support those in the hotel and hospitality industry, and
transportation industries.
The administration recognizes this economic contribution,
and has placed priority on expanding access to public lands and
fish and wildlife resources. Last month Secretary Zinke signed
a new Secretarial Order to increase opportunities for outdoor
recreation and enhanced-conservation stewardship. On the PRA,
we are exploring the most effective and least burdensome way to
collect information from our constituent groups that will allow
us to deliver our mission.
We recognize, though, that even with the PRA, information
collection can be a burden on the public, so we strive to limit
the information and paperwork requirements we place on the
public, balancing our data and information needs with the
associated burden. One way we accomplish this is by making a
number of resources available electronically through our web
page.
Hunters in certain States can now go online to purchase the
required Federal waterfowl hunting permit known as the Duck
Stamp. These electronic Duck Stamps are available for immediate
use, saving hunters time that can be better spent in a duck
blind. The Service will continue to balance our information
evaluation needs with the burdens we place on the public
through implementation of the PRA, and other efforts.
We look forward to working with the Committee to find ways
to continue to collect essential information to support our
mission while minimizing associated burden on the public. And
we are happy to answer any questions that you or the members
may have. Thank you.
Chairman CHABOT. Thank you very much. Mr. Ahluwalia, you
are recognized for 5 minutes.
STATEMENT OF GUNDEEP AHLUWALIA
Mr. AHLUWALIA. Good morning, Chairman Chabot, Ranking
Member Velazquez, and Members of the Committee. I am Gundeep
Ahluwalia, Chief Information Officer of the Department of
Labor. Thank you for inviting me here today to discuss DOL's
efforts to reduce paperwork burden through compliance with the
Paperwork Reduction Act.
As the Department's CIO, I provide strategic leadership for
the Department's IT programs, staffing and services. The
Department is committed to reducing the paperwork burdens on
Americans, the Paperwork Reduction Act being an important tool
for DOL and all Federal agencies.
In carrying out the DOL's broad and varied mission the
Department administers more than 180 Federal laws. DOL programs
cover workplace protections, economic security and benefits,
workforce development, and labor-related statistical programs,
and all of these entail information collection as outlined in
my written statement.
Some requirements help the Department to hold those who do
not comply with worker protection standards accountable. Others
provide for employees and employers to share information to
facilitate compliance reducing the need for our intervention.
Other information collections allow the Department to provide
important economic statistics that enable decision-makers at
all levels of the government and in the private sector to make
informed decisions.
In administering these 180 laws the Department actively
seeks to minimize the paperwork burden it imposes on the
American public, while maintaining its mission and fulfilling
its statutory and programmatic responsibilities. DOL currently
maintains an inventory of 467 active information collections,
with a combined burden of 168 million hours. The Office of
Chief Information Officer submits about 300 information
collection requests (ICRs) a year for OMB's consideration.
I am pleased to report that DOL's paperwork time burden has
remained virtually flat over the last 12 years, the last time
our CIO testified in front of a congressional committee on this
topic. As a mission-critical responsibility DOL has established
well-defined policies and procedures for implementing and
managing PRA and the lifecycle of each information collection.
Effectively managing the lifecycle allows the Department to
control the amount of burden it imposes. We employ five key
strategies to reduce the burden on the American public and
businesses: review all rulemaking actions, assessing the use of
technology, the routine review of information collection
activities, burden reduction initiatives, and public
consultation.
The Department also has a very strong program of compliance
assistance. We maintained a National Contact Center that may be
reached at 1-866-4-USA-DOL or through our website. The
Department's Employment Law Guide describes the major statutes
and regulations that affect businesses and employees, and the
Department's Employment Law Systems for Workers and Small
Businesses, our E-Laws Program, includes interactive eTools to
assist with navigating and interpreting the law.
Online systems for information submission provide ease for
all Americans, including small business owners. Our
Benefits.gov Program, an interagency e-Gov initiative that
includes 17 cabinet-level agencies, offers a gateway to about
1,200 assistance programs across the Federal and State
governments.
Through the Benefits.gov platform, DisasterAssistance.gov
recently received more than 30 million sessions, during which 3
million hurricane survivors completed online applications for
much-needed assistance. DOL has been supporting FEMA through
record levels of online traffic to assist with recovery efforts
in the recent hurricanes that have impacted the U.S.
As a former small business owner myself, I appreciate this
opportunity to discuss DOL's effort to provide relief and fair
treatment to all business owners, particularly small ones and
individuals. The Department is committed to reducing
unnecessary burdens on all U.S. employers and the American
public.
Thank you. I will be happy to respond to any questions.
Chairman CHABOT. Thank you very much. Mr. Simpson, you are
recognized for 5 minutes.
STATEMENT OF TODD SIMPSON
Mr. SIMPSON. Thank you, Mr. Chairman, Ranking Member
Velazquez, and Members of the Committee. My name is Todd
Simpson. I am the chief information officer for the U.S. Food
and Drug Administration, part of the Department of Health and
Human Services. Thank you for inviting me here today to testify
about the Paperwork Reduction Act,
FDA has extensive experience dealing with small businesses.
For instance, approximately 95 percent of U.S. medical
device manufacturing establishments have fewer than 500
employees. We balance the need to collect the information
necessary to carry out our mission with the desire to minimize
the burden on the businesses that feed the Nation and develop
lifesaving medical products.
To assist businesses in filing paperwork that is timely and
accurate, we employ seminars, workshops, educational
conferences, information materials, and contact via email and a
toll-free telephone number. We also offer access to regional
small business advisors and administrative and scientific
support.
FDA is making major investments in technical infrastructure
to improve the customer experience. We have revamped our
website to make it more user-friendly. It now presents the
public with information broken down by product. It contains a
section aimed at small businesses and includes an improved
search engine.
I would be happy to walk you through some of the ways FDA
seeks approval to collect information for use by the agency.
For collections of information in any form or format, including
those contained in regulations, guidance documents, forms,
surveys and studies, focus groups, customer satisfaction
surveys, and message testing, FDA must first receive OMB
approval.
FDA also seeks OMB approval for extensions of currently
approved collections of information. For instance, when FDA
conducts notice-and-comment rulemaking to issue a new
regulation, the comment period for the information collection
provisions is normally 30 days. Comments are sent to OMB and
FDA transmits the information collection request, or ICR, to
HHS, which reviews and certifies the proposed collection. HHS
then sends the ICR to OMB, which files comments on the proposed
rule and approves any collection of information at the final
rule stage.
For ongoing collections of information such as those in
regulations, FDA must go through PRA notice and comment
procedures and request an extension of OMB approval every 3
years. For example, the regulation that covers the information
collection associated with the pre-market approval requirements
for new drugs has been approved every 3 years since the initial
approval in 1977.
FDA also uses forms as an efficient way to collect
standardized information. For example, FDA has forms that
healthcare professionals, patients, and consumers use to submit
adverse event reports. The data from these reports help FDA
assess and evaluate the risk associated with the product. These
forms allow FDA to consider what action may be necessary to
reduce, mitigate, or eliminate the public's exposure to the
risk through regulatory and public health interventions.
FDA has several generic clearances in place for conducting
focus groups, customer satisfaction surveys, rapid response
surveys, and user and message testing. Generic clearances can
be used when an agency seeks to conduct a series of collections
of information using very similar methods, and generally cover
collections of information that are voluntary, low burden, and
uncontroversial,
The plan for the series of information collection goes
through the normal public notice and comment procedures
required by the PRA, but the agency is not required to seek
further public comment on the specific information collection
it conducts under the generic clearance.
Instead, the agency may submit the information collection
instrument directly to OMB for review and approval. Under the
generic clearance for FDA focus groups, FDA recently reviewed
approval of a focus group entitled ``Studies to Enhance FDA
Communications Addressing Opioids and Other Potentially
Addictive Pain Medications.''
This project is designed to provide FDA centers, the Drug
Evaluation and Research, with a better understanding of current
knowledge, practice, beliefs, behaviors, and perceptions about
opioid use, misuse, and abuse among health care professionals,
patients, and other members of the lay public. Gaining this
knowledge will assist in more appropriate, directed, and
focused communication efforts, aimed at raising awareness and
educating the public.
Thank you again for inviting FDA to testify. I would be
happy to answer any questions you may have.
Chairman CHABOT. Thank you very much. And now the chair
will recognize himself. I will begin our 5-minute questioning.
And Dr. Fine, I will begin with you.
Small businesses' stakeholders are concerned that multiple
agencies are asking for the same information when filling out
forms and other paperwork requirements. Is the EPA doing
anything to coordinate within the Agency and also across with
other government agencies to ensure that the government is not
collecting duplicative information?
Dr. FINE. We work, as part of our standard process, to
check and see if other agencies are collecting the information
that our staff, our programs are seeking. We look at some
standard references such as provided by the National Archives
and Records Administration, catalogues any information public.
Also, the people who prepare our information collection
requests are experts in their field and are expected to have
some knowledge of other information that is collected across
the government. When we find opportunities to reuse information
that becomes part of our standard practice.
Chairman CHABOT. Okay. Thank you very much. Mr. Guertin,
I'll move to you next. In your testimony you mentioned that the
Fish and Wildlife Service has many paperwork requirements for
the hunting and angling community in particular. Does the
Service consult with small businesses in those industries to
ensure it is reducing paperwork burden? And if so, how? And how
often would you do that sort of thing?
Mr. GUERTIN. Thank you for your question, Mr. Chairman.
Yes, we work very closely with the large manufacturers and the
wholesalers and retailers at all levels of the distribution
chain to try to get the information we need, whether it is on
what they are producing or how they are selling that to the
public. And then our interest is to take that as associated
with fishing and hunting success.
There are a number of forms. We work with these groups to
make sure we are reducing burden. And Secretary Zinke this past
summer has had several high-level industry summits with
manufacturers, with the recreation vehicle associations, with
hunters and anglers as well, to work with their trade groups on
ways to streamline engagement with the Federal agencies and
support small business while minimizing the collection of
information from the Federal agencies.
Chairman CHABOT. Thank you very much. Mr. Ahluwalia, I will
go to you next. Your written testimony states that the time
burden for the Department of Labor's information collection
request has remained virtually unchanged from what it was 12
years ago. How has the Department of Labor managed to double
the number of information collection requests, but still
estimate the total number of hourly burden to be essentially
the same?
Mr. AHLUWALIA. Thank you for the question. So, the number
doubling is basically responding to program needs over a period
of time. These 467 information collections that we maintained
are like bank accounts, and we do about 300 transactions a year
on them.
Some of these can be to adjust it to mission needs or a
change in a law, or sometimes reducing the burden, sometimes
increasing it. So, even though the number itself has gone up,
the burden has remained flat over a period of time. And I would
argue, over 12 years, if you account for all the growth and the
population growth, et cetera, that is actually effectively a
drop. But that is the explanation for why the number has
doubled while the burden has remained what should be flat.
Chairman CHABOT. All right. Thank you. And I will conclude
my questioning with you, Mr. Simpson. What is the FDA doing to
make sure small businesses can more easily determine what
labeling is required for their businesses? Does FDA have
resources for small businesses to easily navigate the labeling
system?
Mr. SIMPSON. We employ seminars, workshops, educational
conferences, information materials, and of course the toll-free
number, and help by email to provide access to small business
advisors and any kind of administrative support staff that may
need help with that. But as far as the actual labeling
guidelines go, that is slightly outside of my purview as CIO.
Chairman CHABOT. Thank you very much. I am going to yield
back my time and recognize the ranking member for 5 minutes.
Ms. VELAZQUEZ. Thank you. My first question is for the
entire panel. And Dr. Fine, if you could start. Some have
suggested that to make the PRA more effective the volume of
requests being sent to OMB should be reduced. This could be
done by limiting OMB review to significant paperwork
collections and shifting more responsibility to the agencies.
Do you believe that delegating more authority to agencies
unless significant information requests will help a wider focus
on bigger paperwork issues?
Dr. FINE. I do.
Ms. VELAZQUEZ. Without compromising the public policy
goals, right?
Dr. FINE. I do. That allowing the simpler and smaller ones
to go through without that extra step would, I think, save OMB
effort, would also save our Agency effort that we could invest
in greater scrutiny on the larger and more significant
requests.
Ms. VELAZQUEZ. And how would you envision this delegation
to happen?
Dr. FINE. I would expect there would be some criteria by
which Congress and/or OMB decide that below this threshold in
terms of perhaps number of people or a number of anticipated
burden hours that perhaps delegation could be provided to the
agencies.
Ms. VELAZQUEZ. Thank you. Mr. Guertin?
Mr. GUERTIN. We don't have certainly the volume and
workload some of these other large agencies do. We do about 2.7
million annual responses and about 1.7 million burden on the
public, totaling about 11 million in fees charged to them. That
said, though, we have been working very closely with OIRA at
OMB on trying fast-track or do programmatic clearances to batch
some of these added requests into logical building blocks.
And this notion or strategy of them delegating some of that
back to us would be, I think, a very effective tool to set a
threshold or volume up where the agencies had prerogative to
operate within that window, and then elevate the larger, more
challenging packages over to OMB.
Ms. VELAZQUEZ. Thank you. Mr. Ahluwalia?
Mr. AHLUWALIA. Thank you. So, we work very effectively with
OMB at this time to manage our paperwork burden. It is a
challenge to have one size fits all, so whether you are
collecting things from 10 people and it is a hundred hours or
it is a million hours, you are collecting from 100,000 people.
It has to go through the same process.
So that does present its own challenges, and I think a
little bit of more autonomy, while it helps, I am reluctant to
prescribe a formula, though. I think the problem needs a little
more analysis to----
Ms. VELAZQUEZ. But you don't see the value on delegating to
the agencies, you know, less significant information requests,
so that then OMB will focus on the big paperwork issues?
Mr. AHLUWALIA. I do clearly see that value. Yeah.
Ms. VELAZQUEZ. Yes, sir, Mr. Simpson?
Mr. SIMPSON. I, too, see the value in that, and I guess I
would defer to the generic clearance process as one of the tool
sets that OMB has provided that we can utilize to see that
through. But also, I just want to go on record, the PRA staff
at FDA work very closely with OMB and work through issues as
they arise on all matters.
Ms. VELAZQUEZ. Thank you. Mr. Guertin, OIRA receives
thousands of information requests to review each year. One way
we could reduce the volume is to extend beyond 3 years the
length of time that OMB approvals are valid, particularly for
routine types of collections. Do you believe that the OMB
approval timetable should be extended?
Mr. GUERTIN. For some of the more routine packages we deal
with, hunter success and the number of animals taken, I think
that would be very appropriate. If something started, covering
over the area, OMB had a significant policy interest; or a
national issue that was important they may want to retain that
3-year check-in to make sure there were no bigger issues
arising.
Ms. VELAZQUEZ. Sure. Dr. Fine?
Dr. FINE. I agree with what Mr. Guertin described, that
there would be some value in that with appropriate limits to
make sure the public interest was served.
Ms. VELAZQUEZ. Sure. Thank you. Thank you, Mr. Chairman. I
yield back.
Chairman CHABOT. The gentlelady yields back. The gentleman
from Mississippi, Mr. Kelly, who is the chairman of the
Subcommittee on Investigations, Oversight, and Regulations, is
recognized for 5 minutes.
Mr. KELLY. Thank you, Mr. Chairman and Ranking Member. And
thank you, witnesses, for being here. I think sometimes we
forget in government that our purpose is to serve the people,
not them to serve our agency, whatever that may be, whether it
be Congress or the EPA or the Fish and Wildlife. And I had a
small business, a private law practice, and so I started, and
so I thought I was going to practice law. That is what I went
to law school to do, was to be a lawyer and to do trials and to
help people.
But I spent an inordinate amount of my time doing
bookkeeping, deciding what supplies we need, when to upgrade
equipment, where to get insurance from, and what type of
insurance I needed. And so I wound up spending probably 60 to
70 percent of my time doing things other than practicing law,
doing payroll for my employees, paying taxes.
I didn't have to deal with the small business side of that
or filling out additional surveys, and I think sometimes we
think it is not that big a deal. But let me tell you, I am in
the Guard also, the National Guard, and I was writing down just
the surveys that I have done. I get survey requests all the
time that I am required to do, okay, I don't get paid for them.
I had to do my Periodic Health Assessment online and answer
questions which took 30 or 45 minutes. I have to do a training
class for the Blended Retirement System, I have to do sexual
harassment training, and all that online, which I don't get
paid for.
I had to do my credit card to teach me how to use a
government credit card that I have been using for 32 years. I
had to do training on that that lasted an hour and a half or
two. And I also had to do a travel--I had to fill out a
government travel thing, which I have been doing successfully
for the last 15 years, because some bureaucrat decided that I
needed this hour training.
And I am scared to death that we are doing the same thing
with our small businesses. The purpose is not to get
information for any of your agencies, the purpose is to make
these small businesses productive. And I hope that at some
point we will understand that we have to do that.
So, what alternative means are you using to get there? And
here is one other thing, if you had to pay by the hour for the
amount of time that these small business owners had to do, and
you had to pay them out of your budget and you didn't get any
appropriations for that, out of your budget, would you request
the same information? If you will start. What alternative
messages or methods are you using to collect information? And I
will start with you, Dr. Fine.
Dr. FINE. Thank you for the question. And I do understand
the concern both from the small business perspective and as a
Federal employee. I have taken mandatory training. One of the
things we are doing is to try to use--make greater use of
information technology.
There are ways that we can make it easier for people to
fill out required information and take less of their time to do
that, for instance by catching errors right away so there isn't
a back-and-forth. We also, when we do have a need to collect
information, we actually call individuals as part of our
process to see what would the burden be. You know, are there
ways where we can collect this information more effectively?
So, it is not just somebody in Washington making those
decisions. We actually reach out across the country to affected
parties, as well as having public Federal Register notices, so
it would get broad input as well. So, we are actively seeking
input from the regulated groups and from others on ideas.
Also, we do check and see if other agencies are already
collecting the information; no need for us to collect
duplicative information. Hopefully, that helps answer your
question.
Mr. KELLY. And one of you other gentlemen, and either one
of you three, if you had to pay for the information to create a
data bank like most civilian things do, if they want data on
something, they have to pay to create that data. What are you
doing to make sure that there is a test in the public that
says, if I had to pay for it, would I pay for it or not, to
decide what we want to know versus what we need to know?
Because those are very distinct things, and either one of you
three gentlemen can respond.
Mr. GUERTIN. Congressman, I would go back to my example of
our wildlife management objectives with waterfowl. We rely to
the best we can on scientific surveys. We apply a lot of
surveys in the breeding grounds. We do a lot of GIS map
habitat, and we don't go out to the public unless we need to.
The key missing piece of information for us is actual harvest,
hunter success.
And so we have put a lot of this feedback from the public
on our web page. Hunters can just let us know how many ducks
they are taking. We also have voluntary programs like annual
Wingbees, where folks can just send an envelope in with some of
the tail feathers from birds. We can, on a voluntary basis,
collect that. We are trying to balance the benefit we can give
the public with a stronger season each year, bigger bag limits,
more hunter opportunity and success, and minimize the actual
reporting that comes in from our constituent groups.
Mr. KELLY. And Mr. Chairman, I yield back. Thank you.
Chairman CHABOT. Thank you. The gentleman's time has
expired. The gentleman from Nebraska, Mr. Bacon, is recognized
for 5 minutes.
Mr. BACON. Thank you. And as a 30-year Air Force exec, I
can appreciate all those training requirements he went through.
I had to do a bunch of that myself. And thank you all for being
here.
I just want to start off by saying, I am from the Omaha
area. Our small businesses are the local farmers, folks who are
putting up wind generation. I will just let you know, I get
feedback in all four of your agencies of that friction of them
trying to perform and make a profit, and some of the pushback
of the red tape and bureaucracy, so there is always those
impacts on those small businesses, as you all know.
Let me just start off with a question for Mr. Fine, if I
may. At our March meeting we had a witness testify that
agencies required duplicative recordkeeping requirements for
different programs, but from within the same agency. Examples
of EPA's regulations regarding spill prevention regulations and
stormwater pollution, prevention regulations where these two
programs require a lot of the same information from the same
business.
What is the EPA doing to identify instances where just
asking for the same information from a business, but for
different reasons?
Dr. FINE. Thank you very much for that question. The people
in the Agency, who developed these information collection
requests, are experts in their field and are familiar with
information that has been collected within the Agency, and
should be familiar with the information collected outside the
Agency. As an example, the example that came up in the March
hearing was, if I remember correctly, both stormwater and spill
requests.
Mr. BACON. Mm-hmm.
Dr. FINE. And they are serving different purposes, a lot of
the information is different. The stormwater is routine
releases, it rains and you get stormwater runoff. The spill is
an exceptional event, so there are a lot of different
information collected, but there is some small overlap
information.
So that in developing our programs we have allowed
businesses to say, we have a comprehensive plan to address one
of the information collection requests, and have the other
information collection request refer to that, instead of
submitting the duplicate of information. So the staff have
awareness of that and take that into account when designing
this information collection request.
Mr. BACON. Okay. Thank you. Maybe related to this, we have
examples where agencies ask for some duplicate information from
within an agency. How can we do better when multiple agencies
are asking for the same information? So we had, also in March,
we have heard about lead paint, and different agencies wanting
the same information. Is there a way that instead of putting
the burden on the small business, is there a way to put the
burden on the Federal Government to streamline that? Whoever
would like to respond.
Mr. AHLUWALIA. So the Occupational Safety and Health
Administration at the Department of Labor works very hard
across agencies as well to make sure that we, in the initial
stage itself, reduce any redundancy from that perspective. Once
we go further down, there is a recurring cycle of revisiting
these and we try and minimize any redundancy.
Under the Small Business Regulatory Enforcement Fairness
Act, SBREFA, OSHA engages with small businesses quite a bit. We
develop special aids and things that would allow them to
understand, What is the overlap? Why is it different? What am I
getting out of this? I think that that appreciation sort of
helps a little bit as well. We work very hard to reduce that
overlap.
Recently there was WIOA, which is the Workforce Innovation
and Opportunity Act that was passed. And there, Congress
actually built into the act the collaboration between us,
Department of Education, HHS, to go out and work with the
States together. And that is why in that particular case
Department of Labor is the lead agency in managing the
information collection on behalf of all the aforementioned
Departments to implement aspects of that act. So we do a lot of
things. More can be done and obviously we will look for the
opportunities to do it.
Mr. BACON. I appreciate that. Anybody else? Dr. Fine?
Dr. FINE. I will just add, the example came up in March
again with lead paint. The two agencies are looking at
different missions: OSHA is obviously working to protect the
health of the workers, EPA is looking at the people who are
living there.
Mr. BACON. Right.
Dr. FINE. So we are, in that case, focused on the most
sensitive population, which is children ages 6 or less, and
that leads sometimes to different measures, different training
required. Somebody who is actually working to make sure they
are protected, they might take different measures if you want
to make sure the people who are living in that house are
protected day-in and day-out.
Mr. BACON. It may be easier said than done, but it would be
nice if we could put it together and have one form, but that
is, I know, for multiple agencies it is a hard task to do. But
it does all fall on the small business person, often two or
three people, having to make a profit and try to work through
all this red tape.
So, with that, I am out of time. Thank you. Mr. Chairman, I
yield back.
Chairman CHABOT. Thank you very much. Thanks. The
gentleman's time has expired. The gentleman from Iowa, Mr.
Blum, who is the chairman of Subcommittee on Agriculture,
Energy, and Trade, is recognized for 5 minutes.
Mr. BLUM. Thank you, Mr. Chairman. Thank you to the
panelists for being here today. I have heard during your
testimony you have uttered the following words more than once,
that your agency ``strives'' to limit--strives to limit--the
information and paperwork requirements we place on the public,
balancing our data and information needs, the government's data
and information needs, with the burdens associated with those
needs.
Now, I am a small business person. There is not a small
business person in my district, in Northeast Iowa, that
believes that statement, not one. Here is your opportunity to
convince them. Go ahead, and whoever wants to take it. I don't
believe you balance those needs, they don't either. Tell me why
I am wrong. Because they just continue to grow.
Mr. GUERTIN. Congressman, I hear you loud and clear. And
you are talking about an aspirational view and the Federal
agencies and a commitment, and clearly we have a lot of work to
do to convince our fellow citizens of our seriousness of
purpose. But we also would stand by the work that we are doing
and are currently doing and plan to do to harness emerging
technologies, to reach more effective partnerships within the
Federal family, to coordinate upfront, and to put as much of
this information needs onto automated systems or frontload it
the best we can to keep minimizing the touch we have out there.
In our case, to deliver our mission some of that
information is critical to help us set these larger frameworks
to support a robust hunting and fishing economy out there. So
our pledge to you is we will do the best we can to continue,
and we will have to earn some more trust and confidence,
clearly, with your constituents and our fellow citizens.
Mr. BLUM. When will small businesses see a reduction in the
paperwork? Because that sounded very nice, it sounds good, it
sounds beautiful, but they are sitting there in Iowa saying,
now this isn't going to happen, it never has in the past.
Mr. GUERTIN. We had a modest reduction of about 25,000
hours of our 11,000 we were involved last year. It is a modest
start in the right direction. We also reduced the financial
burden by about a half-million dollars by moving many of these
systems online. And out of an $11 million program, we think
that is starting to show some progress for our small agency.
Mr. BLUM. Can you imagine if we incentivized your agencies
with bonuses in your paychecks, if you reduced the regulatory
burden on our businesses, I think the results would be amazing
in 6 months. Anybody else? Tell my small businesses why they
are wrong, that they are going to see reduction in paperwork?
Mr. AHLUWALIA. So, I was a small business owner, and I
owned a small business with my wife. And as we were prepping, I
was sort of trying to reflect when we did business, you know,
how did we perceive the whole thing? And I have been on the
other side now, so it is sort of I have the perspective from
both sides.
So my wife reminded me that to maintain our relationship
with FedEx, we had to fill out five forms a month, with UPS
another five. Yet we perceived anything coming out of the
local, State, and the Federal Government to be way more
burdensome, and those forms aren't really to----
Mr. BLUM. Because you have a choice to work with FedEx or
UPS or the United Postal Service, the businesses don't have a
choice. The government shows up with a subpoena in hand and a
bayonet, and it is by force. There is a big difference.
Mr. AHLUWALIA. Right. And there is that, but I am trying to
just share my perspective. I think we probably want to--these
are opportunities for us to put our case forward as to why
these things are important. How are we protecting the
workforce? And strive to reduce the burden over a period of
time.
Our Benefits.gov that I was talking about, that knits about
1,200 different programs across States, and all you have to do
is go in and plug in a few things, and they will tell you which
three, four, five programs that you would be eligible for. And
then you don't fill out or you don't have to go through a
hundred things.
Mr. BLUM. Do most of these information requests come from
Congress or do they come from your agencies internally? Are we,
in Congress, putting the burden on small businesses by forcing
you all to collect data? Or is this, most of this, coming
internally in your agencies? Be quick, I have only got 30
seconds.
Mr. AHLUWALIA. I think there is a bit of both. I would like
to quote the chairman from the last hearing. He said, ``We have
met the enemy, and it is us.'' There is a little bit of that,
but then there are program needs that are defined by the
program areas as well.
Mr. BLUM. I have 15 seconds. I just want to conclude by
saying small businesses have zero--zero--resources available,
none. Every time we ask them for a bit of information, we just
tax them, it is a tax on small businesses. I don't like the
word ``strive.'' Let us just do it. Let us just do it.
My time has expired. I yield back Mr. Chairman.
Chairman CHABOT. Thank you very much. The gentleman yields
back. And just to clarify on the statement about we met the
enemy, and it is us, my staff wrote it, and I think they stole
it from Pogo, which was a comic strip back in the papers before
most of the people in this room were born. I see a few nodding
heads, I won't point out who they are, but it was from Pogo.
That was a pretty good strip years and years ago.
The chair will recognize the gentleman from South Carolina,
Mr. Norman, for 5 minutes.
Mr. NORMAN. I will just echo what Congressman Blum said. I
am a small business owner, we are contractors and developers. I
have had to fill out paperwork every time it rains, the inches
of rain and the amount of sediment that could have washed over
the dams. I have to fill out paperwork on any development we
do. Does the one-eyed bat exist? Does the heelsplitter snail
exist?
It goes on and on. And like the Congressman was saying, it
is time to do something about this.
Now, I know a lot of it may be out of your purview, but one
of the great things about President Trump is, he is cutting
regulations. Of every one proposed, he is cutting two. For the
small business owner that is major. I have had it with
paperwork. I have had it with having to fill out every form in
the world. The FedEx form that you mentioned is a small thing.
I guess my question is, how have you seen his
administration, in your world, cut the regulations? And
secondly, and this is for anybody really, secondly, how much is
required electronically versus having to be put on our dead
trees in a process that are being removed from acres of land?
Dr. FINE. I will start and be brief with the time. EPA has
completed 16 deregulatory actions following up on President
Trump's Executive Order as a start, so far.
And in terms of paper versus electronic, we still collect a
lot of paper, and we would like to collect a lot less paper,
and that is something we were working to accomplish. And the
strategic plan that EPA has developed for the next 5 years
highlights that as one of the goals--one of the methods to
reduce paperwork and burden reduction.
Mr. GUERTIN. Congressman, the new administration has taken
very aggressive steps so far in the Interior Department, our
Fish and Wildlife Service the first day took down a lead
regulation on hunting. And the new administration has continued
to pursue a lot of streamlining efficiencies.
For example, Secretary Zinke just signed out a new
Secretary Order setting page limits and time limits for the
agencies to comply with NEPA requirements that would reduce
these environmental impact statements and EAs down to a much
more size and scope and timeframe envisioned in the original
legislation rather than these very large products that the
public has been seeing in the last few years.
Mr. AHLUWALIA. We currently have a significant reduction in
the information collection burden as a part of the annual
budget process that is currently with OMB. We have an internal
task force that is looking at each program area, trying to find
areas where we can reduce the information collection burden
without affecting our mission needs.
From an IT perspective we almost--in fact, every
information collection goes through that. Are we using IT
properly or not? Are we using mobile devices or not? We
implement a three-click rule. Can I find the information in
three clicks or not? Sometimes it gets very hard.
But we strive to do all of those things in order to make it
easier. That is why I keep referring to our Benefits.gov. I
think it is a success story that we should be copying across
our results as well.
Mr. SIMPSON. Sir, I can't speak directly to the reduction
in regulation under President Trump's administration, but I can
say that we are doing everything in our power at the FDA to
stabilize and invest in our technical infrastructure. We have a
3-year strategic plan which we are walking diligently, which
has a huge customer-facing piece to it. Our goal is to reduce
duplication as much as possible and to make as many paper forms
electronic as we can.
Mr. NORMAN. That would be a big help. And I will just say,
that for every dollar that I have to spend filling out these
paperwork, the time, not that you don't take the time to email
and doing it electronically, but it is just a lot less of our
staff's time worked, is a dollar that I can expand our
business, that is a machine I can buy, that is a tractor that I
can put to work.
So, in your role, I would really urge you to support this
President in what he is doing, because I have seen the benefit
of it. And hopefully, as he gets into it and doesn't have as
many people fighting him, we can take it to the next level.
I yield back, Mr. Chairman.
Chairman CHABOT. Thank you. The gentleman yields back.
And in closing, the chair and the other Committee members
would like to thank the panel for sharing this testimony here
this morning on what your agencies are doing to reduce the
paperwork burden on America's small businesses. And I would
note for the record that there was some skepticism expressed by
some of the members that have made much progress recently, or
really that we will make much progress in the future. So, prove
us wrong.
We would love to see you reduce paperwork on the entire
public, but especially America's small businesses because that
is what this Committee is all about, you know, trying to help
those folks.
So thank you very much for your testimony here today. I
would ask unanimous consent that members have 5 legislative
days to submit statements and supporting materials for the
record. And without objection, so ordered.
And if there is no further business to come before the
Committee, we are adjourned. Thank you very much.
[Whereupon, at 12:00 p.m., the Committee was adjourned.]
A P P E N D I X
Testimony of Dr. Steven Fine
Acting Assistant Administrator
Acting Chief Information Officer
Office of Environmental Information
U.S. Environmental Protection Agency
before the
Small Business Committee
U.S. House of Representatives
October 11, 2017
Good morning, Chairman Chabot, Ranking Member Velazquez and
Members of the Committee. I am Steve Fine, acting Chief
Information Officer at the Environmental Protection Agency
(EPA). Thank you for the opportunity to discuss the EPA's
implementation of the Paperwork Reduction Act (PRA).
Congress has charged the EPA with enforcing several
statutes to protect human health and the environment. In order
to ensure the requirements of these statutes are met, the EPA
must collect information from the public. EPA has just over 400
OMB-approved collections with a total overall burden of
approximately 174,000,000 hours. This is approximately 1.5% of
the total federal government burden. EPA collections range from
over 21,000,000 hours for the National Pollutant Discharge
Elimination System (NPDES) Program to less than 10 hours for
the Mobile Air Conditioner Retrofitting Program. The agency is
cognizant of the impact these collections have on small
businesses and other entities and works to find ways to reduce
that burden while satisfying the responsibilities assigned by
statutes.
Implementation of the Paperwork Reduction Act
The PRA mandates that federal agencies follow a necessarily
robust process to ensure that they are only collecting
information that is needed and are doing so in the least
burdensome way possible. Under the PRA, an agency must obtain
approval from the Office of Management and Budget (OMB) before
using identical questions to collect information from 10 or
more persons, even if responding to the request is voluntary
for the recipient. To gather information in such circumstances,
the EPA must prepare an Information Collection Request (ICR),
which describes the information to be collected, gives the
reason the information is needed, and estimates the time and
cost for the public to answer the request. Examples of
information collections include surveys, permit applications,
questionnaires, and compliance reports.
At the EPA, subject matter experts in program offices--who
are familiar with the requirements of the program, the
information being collected and the affected public--develop
ICRs. Each program office follows a process established by
EPA's PRA office.
ICRs are subject to a 6- to 10-month internal agency review
and approval process. The agency's PRA office conducts an
independent review of each ICR, and each ICR is also shared
with the public twice for comment via Federal Register Notices.
In addition, the agency consults with a sample of affected
entities. Agency ICR preparers and reviewers consider factors
such as whether the collection is required to achieve the
stated environmental objective, whether there is practical
utility to the information being collected, whether the
proposed collection method is appropriate and efficient,
whether less frequent collection of information would be
sufficient, whether the calculation of the estimated burden is
accurate, and whether the information is collected elsewhere.
Public comments inform agency reviews. After agency review,
ICRs are sent to OMB for further review.
Approved ICRs are valid for up to three years. If data
collection will continue beyond that timeframe, an ICR must be
renewed. The review process for a renewal includes the same
evaluations as are conducted for a new information collection.
Burden Reduction Efforts
The EPA is sensitive to the burden it places on regulated
entities and uses multiple approaches to reduce unnecessary
reporting and recordkeeping burdens on the public. For example,
both the program office and the ICR office independently
consider whether each part of a proposed information collection
has practical utility, is limited in scope to only that
necessary for the intended purpose, and imposes the least
burden.
Also, where feasible, the agency obtains information from
other federal sources, instead of the public. For example,
instead of requesting some information from coastal states that
are seeking final approval of their Coastal Nonpoint Pollution
Control Programs, the EPA obtains that information from the
National Oceanic and Atmospheric Administration (NOAA), which
collects that information for its own needs.
Additionally, the EPA is increasingly using information
technologies to reduce burden by streamlining the information
collection process. For instance, the Toxics Release Inventory
(TRI) involves reporting by more than 20,000 companies per year
and has been a flagship for electronic reporting since 2002.
This year, the EPA enhanced TRI's primary submission
instrument, which is used by thousands of facilities to
describe their toxic chemical inventories and document
significant events (releases, transfers, disposals, etc.). The
enhancements included new features such as automated data
quality checks and a simplified password resetting process.
These enhancements are expected to reduce average reporting
time by 13% for each of the approximately 80,000 forms
submitted annually. Another example is new software systems
under development that are anticipated to reduce reporting
burdens related to public water systems by 23%.
Further, the agency is in the process of developing a
Strategic Plan covering Fiscal Years 2018-2022. The draft plan
shared with the public for comment includes a strategic measure
for the reduction of reporting burden on the regulated
community. This would be one of roughly two dozen measures that
would be tracked at the highest levels of the agency.
The EPA remains committed to working with small businesses
and other regulated entities to find ways to collect the
information we need to protect human health and the environment
in the least burdensome manner possible. Again, thank you for
this opportunity to testify. I would be happy to answer any
questions you may have.
Testimony of Stephen Guertin
Deputy Director for Policy, U.S. Fish and Wildlife Service,
Department of the Interior
Before the House Committee on Small Business
``Evaluating the Paperwork Reduction Act Part II: Are Burdens
Being Reduced?''
October 11, 2017
Introduction
Good morning Chairman Chabot, Ranking Member Velazquez, and
Members of the Committee. I am Stephen Guertin, Deputy Director
for Policy for the U.S. Fish and Wildlife Service (Service).
The Service's mission is ``working with others to conserve,
protect and enhance fish, wildlife and plants and their
habitats for the continuing benefit of the American people.''
The Service is the oldest Federal conservation agency, tracing
its lineage back to 1871, and it is the only agency in the
Federal government whose primary responsibility is conservation
of fish and wildlife resources for the American public. The
goal of the Service and this Administration in the area of
information collection is to reduce burdens and improve
efficiency; and in general, be a good neighbor and partner to
the public and the states.
I appreciate the opportunity to testify before you today on
the Paperwork Reduction Act (PRA) of 1995, as amended. The PRA,
signed into law in 1980 and reauthorized in 1995 (P.L. 104-13,
44 U.S.C. 3501 et seq.), provides the statutory framework for
the Federal government's collection, use, and dissemination of
information. The primary purpose of the PRA is to minimize the
burden of federal paperwork on the public and maximize the
usefulness of the information collected in order to improve the
government's effectiveness. Information collected by the
Service from the public is critical to a number of activities
important to the economy. This includes our work with states to
manage robust and sustainable migratory bird hunting
opportunities for the public in states along migratory bird
flyways. This is a significant economic driver for small
businesses and local economies across the country.
Implementation of the Paperwork Reduction Act
The PRA applies broadly across federal agencies and its
mandates cover a wide range of information--collection
requirements and activities. The Service's information
collection cover a number of activities, including hunting and
fishing license applications and reports; migratory bird and
eagle permit management; fish and wildlife import/export
compliance; annual surveys of fishing, hunting, and wildlife-
associated recreation; marine mammal marking, tagging, and
reporting requirements; Federal subsistence regulations;
international conservation grant programs; and migratory bird
surveys. The Service currently has 44 active collections
comprised of 2,670,931 total annual responses, 1,684,915 total
annual hours, and $11,360,763 total annual costs. In our most
recent 2017 Information Collection Budget submission, we
reported to the Office of Management and Budget's Office of
Information and Regulatory Affairs (OMB-OIRA) a decrease of
24,863 burden hours and a decrease of $497,080 annual costs.
Within the Department of the Interior (Department), the
Service is responsible for its own information collection
process, which is under the oversight of the Department's
Information Collection Clearance Officer, who also provides
guidance and support to the Service as needed. This includes
the preparation of requests to OMB-OIRA for approval of all
information collections. The PRA and Service's Information
Collection Clearance Program ensure that the requirements the
Service places on the public (e.g., individuals, private
sector, and state/local/tribal governments) are justified and
controlled. It is a priority of the Service to ensure all
information collected from the public adheres to the
requirements of the PRA, OMB-OIRA regulations and guidance, and
other applicable laws.
The Service's various program areas work closely with our
Information Collection Clearance Officer (ICCO) to determine if
an information collection requires clearance from OMB-OIRA. If
required, the responsible program works with the ICCO to obtain
OMB-OIRA's approval and clearance prior to information
collection. The ICCO reviews all draft PRA submissions to
ensure the burden placed on the public is reasonable and that
the Service considered all comments and suggestions from the
public. The Department's Information Collection Lead reviews
and approves all Service submissions under the PRA before
formally submitting the packages to OMB-OIRA. The Service does
not make exceptions to legal requirements of the PRA,
recognizing that the authority rests solely with OMB-OIRA.
Public participation in the information collection process
is important to the Service. As required by the PRA, the
Service seeks public comment before requesting or requiring
information from the public. For each collection, we publish
two separate notices in the Federal Register. The first notice
opens a 60-day comment period through which the public sends
comments to the Service ICCO. The ICCO works with the relevant
Service programs to incorporate and address the comments in the
final information collection package. Prior to transmitting the
information collection to OMB-OIRA, we publish a second notice
to give the public a 30-day opportunity to provide comments on
the information collection directly to OMB-OIRA, with a copy to
the Service ICCO. In addition to the above public comment
periods, the Service conducts targeted outreach to individuals
to ensure that we are reducing the impact to the public to the
greatest extent practicable. Through this targeted outreach,
the Service seeks to solicit comments from a sample pool of
respondents reflective of potential respondents to the
information collection.
It is essential for the Service to understand and solicit
feedback on both the time and cost burdens placed on small
businesses. If an information collection affects small
businesses, the Service ICCO works to ensure the targeted
outreach process includes a representative sampling from small
businesses. We document the results of this targeted outreach
in the final information collection package and note whether we
adjusted the collection based on feedback received through this
targeted outreach. Adjustments to the packages may include
adjusting burden estimates as appropriate; consolidating
similar information collection instruments to streamline
compliance; and automating processes to reduce burden time on
respondents whenever possible.
Balancing Information Collection Needs with Public Burden
The Service strives to limit the information and paperwork
requirements we place on the public, balancing our data and
information needs with the burdens associated with those needs.
One such example is the collection of harvest information from
migratory bird hunters, which enables us to develop sound,
science-based hunting guidelines. Harvest surveys allow the
Service to gather information on hunter participation, success
rates, and target species. We use this, and other types of
information, to inform our regulatory decisions so that
regulations result in sustainable hunting guidelines that
ensure maximum hunting opportunities for the public each year.
An example of how we use information collected from the
public is a recent change to hunting guidelines for black
ducks. In 2017, the Service expanded the harvest of black ducks
based on information from banding studies and the harvest
survey program. Our science is well established, and we can
demonstrate that populations remain healthy.
The Service places great priority on expanding public
access to fish and wildlife resources while maintaining the
sustainability of those resources so they can be accessed by
the public in future years. We depend on information collected
from the outdoor-recreation community in order to do so. The
Service recognizes that hunting, fishing and other wildlife-
based recreation is not only an important leisure pastime and a
way for people to bring food to the table, but it is also a
catalyst for economic activity, creating jobs supporting small
businesses across the nation. Hunters, anglers, and wildlife
watchers spent more than $156 billion on wildlife-related
recreation in 2016. This spending contributed to local
economies throughout the country, which improved employment,
raised economic output, and generated tax revenue.
Efforts to Improve PRA Compliance
The Service is working to further reduce the burden of
information collections on both the public and our agency's
work. Beyond the standard PRA approval process, the Service
also applies the Department's Programmatic Clearance for
customer satisfaction surveys and the Department's ``Fast
Track'' Clearance for collection of qualitative feedback. These
two processes, when applicable, provide the Service with a
streamlined approach to PRA compliance. For collection of
customer satisfaction data, the Programmatic Clearance process
significantly reduces the time to internally develop and obtain
OMB approval to as few as 45 days, as compared to the six to
nine months it typically takes the Department to develop a
standard PRA package, issue notices and respond to any public
comments, and submit to OMB-OIRA for approval under the
standard PRA compliance process. The Fast Track process is
designed for a wide range of information collections that focus
on the awareness, understanding, attitudes, preferences, or
experiences of customers or other stakeholders. Through this
process, the Service may proceed with the collection in as soon
as five days if OMB-OIRA does not respond with questions,
concerns, or issues identified with the submission.
Other Effects to Reduce Public Burdens
The Service and this Administration place great priority on
being a good neighbor and improving government efficiency. We
are taking actions outside of the scope of the PRA to further
reduce burdens on the public and small businesses. The Service
is working with the Department to implement Secretary's recent
order on streamlining our review processes. One of its primary
directives will reduce paperwork by setting standard page
limits, consistent with Council on Environmental Quality
guidance, for National Environmental Policy Act (NEPA)
analyses. The Secretary's order will also ensure timely
completion of environmental reviews by designating lead
agencies for projects and setting reasonable timelines for
analyses. Implementation of these directives will allow for a
more transparent process and provide businesses and the public
with more certainty.
Through the use of online platforms, the public can quickly
and easily conduct business with the Service that was
previously more time consuming. The Service has endeavored to
make processes easier for the public, as well as to make our
operations more efficient, by making forms available
electronically through our website. The Service has nearly 200
forms available to the public online, ranging from the
``Horseshoe Crab Tagging Release Form'' to the ``Oil and Gas
Operations Special Use Permit Application''. In 2013, the
Service launched an electronic version of the Federal Duck
Stamp that allows users to buy stamps online through
participating state licensing systems. A printed receipt,
available immediately, is valid for 45 days, during which time
a physical duck stamp is mailed. There currently are 23 states
that participate in the e-stamp program. The stamp represents
the permit required by the Migratory Bird Treaty Act of 1918 to
hunt waterfowl and is required to be carried by every waterfowl
hunter who is more than 15 years old.
Conclusion
Through implementation of the PRA, the Service ensures that
our information collections are not unduly burdensome on the
public. We continue to seek improvements in our compliance with
the Act to reduce impacts to the public and our agency's work.
Thank you for your interest in examining the Paperwork
Reduction Act. I appreciate the opportunity to testify and look
forward to working with the Committee on the implementation of
the Act.
STATEMENT OF GUNDEEP AHLUWALIA
CHIEF INFORMATION OFFICER
U.S. DEPARTMENT OF LABOR
BEFORE THE
COMMITTEE ON SMALL BUSINESS
U.S. HOUSE OF REPRESENTATIVES
OCTOBER 11, 2017
Good afternoon, Chairman Chabot, Ranking Member Velazquez,
and Members of the House Small Business Committee. I am Gundeep
Ahluwalia, Chief Information Officer (CIO) for the Department
of Labor (DOL). Thank you for inviting me here today to discuss
DOL's efforts to reduce paperwork burden through compliance
with the Paperwork Reduction Act (PRA). I appreciate this
opportunity to discuss DOL's responsibilities under the PRA and
our efforts to provide relief and fair treatment to all
business owners, particularly small ones, and individuals.
DOL is committed to reducing the burdens that America's
businesses and individuals deal with every day as a result of
Federal regulations and paperwork. The Paperwork Reduction Act
is an important tool for DOL, and all federal agencies, to use
in reducing unnecessary burdens on the American public.
DOL administers three types of information collections
covered by the PRA: recordkeeping, reporting, and third-party
disclosures. In carrying out DOL's broad and varied mission,
the Department administers more than 180 Federal laws. Many of
these laws provide for recordkeeping requirements that allow
the Department to hold violators of worker protection standards
accountable for their non-compliance. Other laws provide for
employees and employers to share information to facilitate
compliance. DOL reporting requirements allow the Department to
provide important economic statistics that enable decision
makers at all levels of government and in the private sector to
make informed decisions. In administering these laws and
related programs, the Department actively seeks to minimize the
paperwork burden it imposes on the American public while
maintaining its mission and fulfilling its statutory and
programmatic responsibilities.
Achieving the aforementioned results is no small task. DOL
currently maintains an inventory of 467 active information
collections with a combined burden of 168 million hours and
nearly $5.7 billion in other costs. Furthermore, the Office of
the Chief Information Officer (OCIO) annually reviews and
submits for Office of Management and Budget (OMB) consideration
more than 300 information collection requests (ICRs). While the
number of ICRs has doubled since the last time a DOL CIO
testified before a Congressional committee in 2005, the time
burden has remained virtually unchanged from the 166 million
hours mentioned 12 years ago. Much of the increased clearance
activity can be attributed to new legislation enacted during
that time.
The Department remains committed to the goals of the PRA
and continues to explore and implement new ways to reduce
burden hours imposed on the public. The Department recently
developed its response to the FY 2017 data call for the
Information Collection Budget (ICB) and is continuing to work
to identify paperwork burden reduction initiatives. DOL employs
several strategies to reduce burden, including:
Comprehensively evaluating and periodically
updating information collections contained in
regulatory text and information collections that
implement regulations but do not themselves rise to a
regulation;
Exploring streamlined information collection
methodologies;
Reducing redundancy; and
Deploying automated information collection
techniques when feasible.
With respect to reducing paperwork burden, OMB has called
on CIOs in Executive Departments and Agencies not only to
consider paperwork burden reduction initiatives that would
serve ICB purposes, but to work more closely with regulatory
policy officials to identify where paperwork burden reduction
initiatives would serve as compliance mechanisms pursuant to
President Donald J. Trump's Executive Order (EO) 13771,
Reducing Regulations and Controlling Regulatory Costs (i.e.,
would serve as an existing regulatory action the agency plans
to eliminate or propose for elimination, consistent with
Sections 2 and/or 3 of EO 13771). As you may know, EO 13771
generally requires agencies to issue two deregulatory actions
for each regulatory action. The incremental costs associated
with the regulatory actions must be fully offset by the savings
of deregulatory actions.
The Department takes the PRA very seriously. As a mission-
critical responsibility, DOL provides full management support
and has established well-defined policies and procedures for
implementing and managing the PRA. The following briefly
discusses DOL's PRA Management structure.
The PRA requires each agency head to designate a CIO to
carry out the responsibilities of the agency under the PRA.\1\
The CIO is responsible for establishing and administering a
process that is sufficiently independent of program
responsibility to evaluate fairly whether a proposed collection
of information should be approved.\2\ Accordingly, the DOL
established such an independent process and issued an internal
policy directive for implementing the Department's information
collection management program.
---------------------------------------------------------------------------
\1\ See 44 U.S.C. 3506(a)(2)(A).
\2\ See 44 U.S.C. 3506(c)(1).
The Department of Labor Manual Series includes a chapter
that establishes DOL's procedures for implementing its PRA
program. This internal policy directive assigns to DOL sub-
agency heads the responsibility of ensuring sub-agency
---------------------------------------------------------------------------
compliance with the PRA and other applicable laws and policies.
Furthermore, the directive assigns DOL's information
collection management to the Departmental Clearance Officer and
DOL sub-agency-level management to Agency Clearance Officers
who manage the PRA program within each DOL sub-agency and
provide both in-depth programmatic and PRA expertise that
further ensures DOL's information collections effectively meet
the PRA's provisions regarding the need for the information,
practical utility of the information collection, minimizing the
public burden for the collection, and enhancing the quality and
usefulness of the information collected.
As part of assigned duties, the Departmental Clearance
Officer manages the day-to-day activities of implementing the
PRA for the CIO. The Departmental Clearance Officer reviews
information collection requirements contained in regulatory
documents and in information collection requests to ensure:
Legal authority or necessity for the
collection of information;
Compliance with the PRA, the E-Government
Act of 2002, Privacy Act, and other applicable laws;
and
The collection imposes minimum burden on the
public and offers practical utility.
Additionally, the Departmental Clearance Officer provides
overall management of DOL's information collection enterprise,
including but not limited to:
Managing efforts to reduce DOL's public
paperwork burden in accordance with applicable laws,
Administration directives, such as EO 13771, and
Departmental guidance and priorities;
Coordinating information collection activity
with OMB and DOL agencies;
Conducting public consultations as required
by the PRA;
Providing training and technical assistance
on PRA requirements;
Managing data associated with DOL's
information collection inventory;
Providing leadership for identifying and
implementing burden reduction strategies; and
Coordinating with other agencies on common
information collections conducted with other
Departments.
Throughout the year, the Departmental Clearance Officer
collaborates with Program Agency Clearance Officers to:
Monitor program performance against the ICB
to ensure that reported goals are realized;
Evaluate program activities to ensure
compliance with the PRA;
Determine the need for an ICR and best
mechanism to obtain clearance; and
Manage the life-cycle of existing
collections of information to ensure continued
effectiveness, efficiency, and utility, and to ensure
that expiring collections are submitted to OMB in a
timely manner.
To help program agencies comply, OCIO also developed an
internal DOL PRA Manual that provides more detailed guidance to
help programs administer their PRA programs. Among other
things, the Manual provides samples of various documents and
templates an agency may use to make common disclosures such as
the PRA's public burden statement.
Through its rigorous internal review process, the
Department aggressively controls the amount of burden it
imposes on the American public and ensures the practical
utility and enhanced usefulness of its information collections
with five main strategies:
1. Review of Rulemaking Actions: This strategy
ensures regulatory actions are based on mission
critical needs and impose minimum practicable burden.
The review ensures that the public burden has maximum
practical utility and public benefit.
2. Assessing the Use of Technology: This strategy
involves implementing the Government Paperwork
Elimination Act of 1998, the Clinger-Cohen Act, E-
Government Act of 2002, and Federal Information
Technology Acquisition Reform Act by strategically
deploying automated information collection techniques
in order to reduce public paperwork burdens.
3. Routine Review of Information Collection
Activities: This strategy involves carefully assessing
all new information collection requests and all
collections of information seeking OMB approval for any
extended or revised information collection requirements
to ensure programmatic necessity, legal authority,
maximum practical utility and public benefit, and
burden reduction strategies.
4. Burden Reduction Initiatives: This strategy
involves initiating systemic enterprise-level efforts
through Departmental burden reduction initiatives, as
already mentioned in the earlier reference to the ICB.
5. Public Consultation: To help ensure the practical
utility of information it collects, including the
frequency and collection methods, the Department relies
heavily on the public consultation process required by
the PRA. Key stakeholders and industry experts are
consulted as part of the Department's rulemaking
process and interested parties as well as the general
public are afforded two opportunities to comment on
proposed information collection activities, which
collectively provide the public 90 days to provide
input on the practical utility of DOL's information
collections as well as provide insights for reducing
the burden imposed. The OCIO encourages DOL program
agencies to make information collections available on
regulations.gov during the initial 60-day public
comment period when comments go to the agency. The OCIO
also provides a direct link to each ICR in the 30-day
Federal Register Notice when the request is submitted
for OMB review. This not only increases transparency;
it allows interested parties to provide more meaningful
comments for the agency to consider.
Through a rigorous internal review process and aggressive
burden reduction strategies, the Department of Labor is
committed to reducing the paperwork burden on the American
public. In addition, the Department has a very strong program
of compliance assistance to help all businesses comply with our
requirements. For example, the Department has a National
Contact Center that may be reached at 1-866-4-USA-DOL or
through a ``contact-us'' feature on the DOL Website. All DOL
agencies provide compliance assistance materials on their
agency Websites, along with local office contact information.
The Office of the Assistant Secretary for Policy (OASP)
maintains the Department's Employment Law Guide which describes
the major statutes and regulations administered by the
Department that effect businesses and employees. In addition,
OASP developed and maintains the Department's Employment Laws
Assistance for Workers and Small Businesses (elaws) Program
which includes more than 30 interactive e-tools that provide
easy-to-understand information about DOL laws and regulations.
Elaws is available 24/7 to assist the public, both employees
and employers, in understanding their roles and
responsibilities to comply with these various laws. Elaws is
available at www.dol.gov/elaws.
Information collection and the ease of submission are
critical for the American public, including small business
owners. Benefits.gov, an interagency e-Gov initiative that
includes all cabinet-level agencies, is an example of effective
and efficient communication between those of us in Government
agencies and the people we serve. Benefits.gov offers over
1,200 assistance programs through its Website and mobile
responsive pages that connect small business and other members
of the public with online applications that provide loans and
other forms of assistance. This online assistance also includes
disaster assistance through the Federal Emergency Management
Agency (FEMA). DOL has been supporting FEMA through record
levels of traffic to assist with recovery efforts for the
recent trio of Hurricanes (Harvey, Irma, Maria) that impacted
Texas, Florida, and other Territories. The value of this cross-
agency initiative is demonstrated by the fact that
DiasterAssistance.gov received more than 29.6 million sessions,
during which 3 million survivors (including small businesses),
completed on-line applications for much needed assistance from
August 25 through the end of September of this year.
That concludes my prepared testimony. I would be happy to
answer questions you may have.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Chabot, Ranking Member Velazquez, and members of
the committee, thank you for inviting me here today to testify
about the Paperwork Reduction Act (PRA). My name is Todd
Simpson, and I am the Chief Information Officer for the U.S.
Food and Drug Administration (FDA), part of the Department of
Health and Human Services (HHS or the Department).
FDA's mission is to protect the public health by ensuring
that foods are safe, wholesome, sanitary, and properly labeled;
that human and veterinary drugs are safe and effective; that
there is reasonable assurance of the safety and effectiveness
of devices intended for human use; that cosmetics are safe and
properly labeled; and that public health and safety are
protected from electronic product radiation, In addition, FDA
promotes the public health by promptly and efficiently
reviewing clinical research and taking appropriate action on
the marketing of regulation products in a timely manner. FDA
also has responsibility for regulating the manufacturing,
marketing, and distribution of tobacco products to protect the
public health and to reduce tobacco use by minors.
FDA balances the need to collect the information necessary
to carry out our mission with the desire to minimize the burden
on the businesses that feed the national and develop life-
saving medical products.
Background
According to 44 U.S.C. 3506, each Agency head is to
designate a Chief Information Officer responsible for carrying
out the responsibilities of the PRA. Under 5 CFR 1320.3,
defining ``agency'' as ``any executive department'', the agency
head for our work is the Secretary of HHS. Accordingly, the
hierarchy for PRA oversight from the Department to FDA is as
follows:
> The Secretary of HHS
> HHS Chief Information Officer
> FDA Chief Information Officer
> FDA PRA Staff
The FDA PRA staff acts as the liaison among FDA program
offices, HHS, the Office of Management and Budget (OMB), and
the public on all PRA-related matters, facilitating all
communications seeking to fulfill the goals of the PRA.
FDA's current inventory of approved information collections
is:
----------------------------------------------------------------------------------------------------------------
Number of Approved Collections Total Burden Hours Total Responses Total Cost
----------------------------------------------------------------------------------------------------------------
274 181,533,621 946,776,091 $3,736,696,238
----------------------------------------------------------------------------------------------------------------
Information Collection Activities
FDA seeks OMB approval for collections of information in
any form or format, including those contained in regulations,
guidance documents, forms, surveys and studies, focus groups,
customer satisfaction surveys and message testing. FDA also
seeks OMB approval for extensions of currently-approved
collections of information.
FDA has several ``generic clearances'' in place for
conducting focus groups, customer satisfaction surveys, rapid
response surveys, and user and message testing. Generic
clearances can be used when an agency seeks to conduct a series
of collection of information using very similar methods, and
generally cover collections of information that are voluntary,
low-burden, and uncontroversial. The plan for the series of
information collections goes through the normal public notice
and comment procedures required by the PRA, but the agency is
not required to seek further public comment on the specific
information collections it conducts under the generic
clearance. Instead, the agency may submit the information
collection instrument (e.g., survey or questionnaire) directly
to OMB for review and approval, which is typically brief.
Regulations
FDA regulations with collections of information may contain
substantive regulatory requirements or can be administrative or
procedural in nature. When FDA conducts notice-and-comment
rulemaking to issue a new regulation, the comment period for
the information collection provisions is normally 30 days
(usually, a longer period of public comments is open on the
substance of the rule). Comments related to the information
collection are sent to OMB. At the time of publication, or
shortly thereafter, FDA transmits the information collection
request (ICR) to HHS, which reviews and certifies the proposed
collection. HHS then sends the ICR on to OMB through the
Regulatory Information Service Center (RISC) and Office of
Information and Regulatory Affairs (OIRA) Combined Information
System (ROCIS). OMB usually files comment on the proposed rule
and approves any collections of information at the final rule
stage.
For ongoing collections of information, such as those in
regulations, FDA must go through PRA notice and comment
procedures and request an extension of OMB approval every three
years. For example, OMB Control Number 0910-0001, ``FDA
Approval to Market a New Drug,'' covers the information
collection associated with the premarket approval requirements
for new drugs and every three years since the initial approval
in 1977, FDA has requested an extension of the approval from
OMB.
Guidance
FDA guidance documents may contain an information
collection that is already covered by an OMB approval. In the
case of an information collection covered by OMB approval for a
regulation, the guidance document would be uploaded in the
ROCIS entry for that rulemaking as an ``instrument'' and would
become part of the ICR for the regulation.
FDA also issues ``stand-alone'' guidance documents that may
contain a new information collection requiring approval by OMB.
Although FDA guidance documents are generally non-binding,
collections of information authorized or mandated by statute
are sometimes implemented through guidance, often because the
statute directs FDA to issue guidance on how to comply with the
statute. Also, FDA may determine it is preferable to issue
guidance with recommendations on how to comply with the
statute, rather than binding regulations prescribing the means
of compliance.
Forms
FDA also uses forms as an efficient way to collect
standardized information. For example, FDA has forms that
healthcare professionals, patients, and consumers use to submit
adverse event reports. The data from these reports helps FDA
assess and evaluate the risk associated with the product. These
forms, from FDA Form series 3500, allow FDA to consider what
action may be necessary to reduce, mitigate, or eliminate the
public's exposure to the risk through regulatory and public
health interventions.
Surveys
FDA may conduct surveys prior to policy decisions or
rulemaking in order to understand a target audience, behaviors,
needs, and opinions. After a regulation or program is in place,
formative research can help to refine and improve activities
and communications. An example of a recurring FDA survey is the
``Food Safety Survey'' (approved under OMB Control Number 0910-
0345). The supporting statement indicates that the data
generated by this survey is a widely accepted source of
information on consumer food handling practices and food
safety-related knowledge, and is used to prepare important HHS
reports such as Healthy People 2020. Telephone interviews are
conducted using a random sample of 4,000 consumers, including
at least 400 Hispanic-Americans and at least 400 African-
Americans. Data from the survey is used in support of FDA's
regulatory policy in diverse areas dealing with food safety and
supports consumer education by enabling FDA to track consumer
knowledge, attitudes, and practices concerning food safety.
The Center for Drug Evaluation and Research (CDER) and the
Center for Tobacco Products (CTP) conduct many studies and
consult with OMB about survey questions, statistical methods,
and intended use of the information. Most studies and surveys
request a one-time approval and do not need to be renewed.
Discussions between FDA and OMB are often held to resolve
differences of opinion on the methodology of surveys FDA wishes
to conduct. At times, FDA must revise the data collection
instrument (e.g., a questionnaire) to obtain OMB approval. With
surveys and other studies, a contract is often involved and
extensions may have to be requested if OMB's review and
approval are not timely.
Focus Groups
Focus groups are one of the ways FDA can gather information
to inform decisions on how to approach a rulemaking or guidance
document. Under the generic clearance for FDA focus groups, FDA
recently received approval of a focus group entitled, ``Studies
to Enhance FDA Communications Addressing Opioids and Other
Potentially Addictive Pain Medications.'' Combating opioid
misuse, abuse, and addiction has long been a priority for the
Agency. Over the last decade or so, FDA has worked to pursue a
targeted, science-based, multi-pronged approach that addresses
misuse, abuse, and addiction at critical points in the
development of an opioid product and in its use throughout the
health care system.
In addition to extensive scientific analysis, FDA has
focused on efforts to raise awareness and educate the public
and health care professionals about opioids and their inherent
safety risks, engaging in public communications and outreach
through multiple avenues, such as public meetings, public
announcements, discussions with experts, and targeted public
outreach. The Agency is committed to ongoing efforts to help
enhance the safe and appropriate use of opioids and supports a
variety of regulatory, educational, communication, and
scientific activities aimed at achieving this goal, both on its
own and in collaboration with other agencies and stakeholders.
FDA has determined further research is needed in order to
better understand how to most efficiently and effectively focus
resources to educate and communicate about opioids and their
safe and appropriate use to various stakeholder audiences.
As a result, this project is designed to provide FDA's
Center for Drug Evaluation and Research (CDER) with a better
understanding of current knowledge, practice, beliefs,
behaviors, and perceptions about opioid use, misuse, and abuse
among several key stakeholder audiences, including health care
professionals, patients, and other members of the lay public.
Gaining this knowledge will assist in more appropriately
directed and focused communication efforts aimed at raising
awareness and educating the public.
Reducing the Impact on Small Business
ROCIS reserves one field for the number of small entity
respondents for which the information collection will have a
significant impact. FDA Centers and program experts provide the
details regarding the impact on small business. For instance,
the Center for Devices and Radiological Health (CDRH) offered
these details regarding the impact on small business in the
supporting statement for OMB Control Number 0910-0844, ``De
Novo Classification Process (Evaluation of Automatic Class III
Designation)'':
Approximately 95% of U.S. medical device
manufacturing establishments have fewer than 500
employees and would, therefore, be considered small
businesses. Submission of a De Novo request is
voluntary. Any impact on small businesses should be
offset by the guidance and consumer assistance
available through CDRH Learn training tools and the
information posted on FDA's website. FDA aids small
business by providing guidance and information through
the Division of International and Consumer Education
(DICE) within the Center for Devices and Radiological
Health. DICE provides technical and non-financial
assistance to small manufacturers, through a
comprehensive program that includes seminars,
workshops, and educational conferences, information
materials, contact via email and the use of a toll-free
telephone number. Other members of the Center staff are
also available to respond to questions at any time.
Additionally, the Manufacturers Assistance Branch in
the Center for Biologics Evaluation and Research (CBER)
provides assistance and training to industry, including
large and small manufacturers and trade associations,
and responds to requests for information regarding CBER
policies and procedures.
In the supporting statement for OMB Control Number 0910-
0614, ``Exceptions or Alternatives to Labeling Requirements for
Products Held By the Strategic National Stockpile,'' CBER
described the extra help it provides to small businesses:
This collection of information applies to both small
and well as [sic] large establishments. Although FDA
must apply the statutory and regulatory requirements
equally to all enterprises, FDA does provide special
help to small businesses. The Center for Biologics
Evaluation and Research, Office of Communications,
Outreach, and Development, Division of Manufacturer's
Assistance and Training, the Center for Drug Evaluation
and Research, Office of Communication, Division of Drug
Information, and the Center for Devices and
Radiological Health, Division of Small Manufacturers,
International and Consumer Assistance provide
assistance to small businesses subject to FDA's
regulatory requirements.
In the supporting statement for OMB Control Number 0910-
0014, ``Investigational New Drug Regulations,'' the Center for
Drug Evaluation and Research (CDER) explained:
FDA's authority and responsibility to ensure the safe
use of investigational drugs applies to small as well
as to large businesses involved in sponsoring drug
studies. FDA believes that its responsibility requires
the equal application of the regulations to all
businesses. While FDA does not believe it can apply
different standards with respect to statutory
requirements, FDA does provide special help to small
businesses. A small business coordinator has been
assigned to the Commissioner's staff to ensure that
small businesses have an adequate opportunity to
express their concerns and to keep FDA management
apprised of how regulatory decisions might impact the
small business community. To provide additional
assistance to small businesses, FDA has established an
office whose exclusive concern is to provide small
business with help in dealing with FDA regulatory
requirements.
FDA's Tools and Resources
FDA provides tools, templates, and resources for Centers to
use when drafting their information collection documents:
Templates for drafting notices for
publication in the Federal Register are made available
by the Regulations Editorial Section, Office of Policy.
FDA developed instructions and a template
for completing the supporting statement that OMB
reviews prior to taking action on an ICR. This template
was developed by the FDA PRA Staff based on
instructions from OMB and HHS and on the requirements
of ROCIS.
FDA established SOPs for use with
information collection in guidance documents through a
cooperative effort between the various Centers, the
Office of Chief Counsel, and the Office of Policy.
FDA provides training to Centers on the PRA
process, including as a part of the Quality System for
Regulations training offered by the Office of Policy.
Thank you again for inviting FDA to testify. I would be
happy to answer any questions you may have.
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