[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
              
              
              
              
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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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