82 FR 42506 - Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 173 (September 8, 2017)

Page Range		42506-42508
FR Document		2017-19047

As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to general regulatory and information collection requirements that affect multiple FDA Centers and/or Offices.

Federal Register, Volume 82 Issue 173 (Friday, September 8, 2017)

[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Proposed Rules]
[Pages 42506-42508]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2017-N-5093]


Review of Existing General Regulatory and Information Collection 
Requirements of the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments and information.

-----------------------------------------------------------------------

SUMMARY: As part of the implementation of Executive Order 13771 
entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and 
Executive Order 13777 entitled, ``Enforcing the Regulatory Reform 
Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is 
seeking comments and information from interested parties to help FDA 
identify existing regulations and related paperwork requirements that 
could be modified, repealed, or replaced, consistent with the law, to 
achieve meaningful burden reduction while allowing us to achieve our 
public health mission and fulfill statutory obligations. This document 
relates to general regulatory and information collection requirements 
that affect multiple FDA Centers and/or Offices.

DATES: Submit either electronic or written comments on this document by 
December 7, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 7, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. 
Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because 
your comment will be made public, you are solely responsible for 
ensuring that your comment does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-5093 for ``Review of Existing General Regulatory and 
Information Collection Requirements of the Food and Drug 
Administration.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff Office between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff Office, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Megan Velez, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993, 301-796-4830, [email protected].

[[Page 42507]]


SUPPLEMENTARY INFORMATION: 

I. Background

A. FDA's Regulatory Mission

    FDA is responsible for protecting the public health by: (1) 
Ensuring the safety, efficacy, and security of human and veterinary 
drugs, biological products, and medical devices; (2) ensuring the 
safety, security, and appropriate labeling of our nation's food supply, 
products that emit radiation, and cosmetics; and (3) regulating the 
manufacture, marketing, and distribution of tobacco products. Equally 
important, FDA promotes the public health by fostering and supporting 
innovative approaches and solutions for some of our nation's most 
compelling health and medical challenges.
    This document is seeking comments and information solely on general 
regulations and approved information collections affecting multiple FDA 
Centers and/or Offices.

B. The Regulatory Reform Agenda: Executive Orders 13771 and 13777

    On January 30, 2017, President Trump issued Executive Order 13771, 
``Reducing Regulation and Controlling Regulatory Costs'' (Ref. 1). This 
Executive Order states that the policy of the Executive Branch is to be 
prudent and financially responsible in the expenditure of funds, from 
both public and private sources, and that it is essential to manage the 
costs associated with complying with Federal regulations. On February 
24, 2017, President Trump issued Executive Order 13777, entitled 
``Enforcing the Regulatory Reform Agenda'' (Ref. 2). The purpose of 
this Executive Order is to alleviate unnecessary regulatory burdens 
placed on the American people. Executive Order 13777 directs each 
Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate 
existing regulations and identify those that may merit repeal, 
replacement, or modification. Section 3(d) of the Executive Order 
provides that, at a minimum, each RRTF must attempt to identify 
regulations that:
     Eliminate jobs, or inhibit job creation;
     Are outdated, unnecessary, or ineffective;
     Impose costs that exceed benefits;
     Create a serious inconsistency or otherwise interfere with 
regulatory reform initiatives and policies;
     Are inconsistent with the requirements of the Information 
Quality Act, or the guidance issued pursuant to that Act, in particular 
those regulations that rely in whole or in part on data, information, 
or methods that are not publicly available or that are insufficiently 
transparent to meet the standard for reproducibility; or
     Derive from or implement Executive Orders or other 
Presidential directives that have been subsequently rescinded or 
substantially modified.

II. Request for Comments and Information

    To assist with our implementation of Executive Orders 13771 and 
13777 and support the work of the RRTF of the Department of Health and 
Human Services, FDA is issuing this Request for Information soliciting 
broad public comment on ways we can change our regulations to achieve 
meaningful burden reduction while continuing to achieve our public 
health mission and fulfill statutory obligations. We request comment, 
including supporting technical, scientific, economic, or other data, 
from all persons and entities significantly affected by FDA 
regulations, including consumers, patients and caregivers, researchers, 
healthcare institutions, the regulated industry, trade associations, 
public interest organizations, academia, and State, local, and tribal 
governments, as well as any other interested stakeholder. These 
comments and data will supplement and inform our own ongoing, 
systematic review of our regulations.
    The following list of questions includes those that FDA is using to 
guide our initial review of our regulations. This list is intended to 
help the public in providing comments, not to restrict the issues that 
may be addressed.
     Is the regulation still current, or is it outdated or 
unnecessary in some way?
    [cir] Have there been advancements and innovations in science, 
technology, or FDA or industry practice, or any other changes that 
suggest repeal of or modification to the regulation may be warranted or 
appropriate?
    [cir] Has the regulation been superseded or made irrelevant or 
unenforceable by statute, another FDA regulation or guidance, a 
regulation by another Federal Agency, or controlling legal authority? 
If yes, identify the statute, regulation, guidance, or legal precedent 
and explain what FDA regulation is affected and in what way it is 
affected.
    [cir] Is this regulation duplicative of requirements in other FDA 
regulations or other Federal Agency regulations? If yes, identify the 
overlapping regulation(s) and responsible Federal Agency and describe 
the way(s) in which the regulations overlap, as well as any suggestions 
with respect to how best to resolve the duplication.
     Have regulated entities had difficulties complying with 
the regulation? If yes, identify what entity or entities have had such 
difficulties and the nature of the difficulties.
     Does the regulation impose requirements that are also 
provided for in voluntary or consensus standards or guidance by third 
party organizations (e.g., International Council for Harmonisation, 
International Organization for Standardization, Codex Alimentarius)? Do 
the entities covered by these standards or guidance take steps to meet 
the standards and to document that they meet the standards? If met, do 
the standards achieve the same level of public health protection as the 
FDA regulation? Are there entities who are not covered by these 
standards or guidances or who choose not to observe them?
     Does the regulation contain redundant, outdated, or 
unnecessary collections of information or retention of records, e.g., 
reporting, recordkeeping, or labeling requirements? Explain in your 
response why the information is redundant, outdated, or unnecessary.
     Could the goal of the regulation be achieved by less 
costly means that would provide the same level of public health 
protection? If yes, provide examples of alternatives that may reduce 
costs to industry while retaining the same level of public health 
protection.
     What factors should FDA consider in selecting and 
prioritizing regulations and reporting requirements for reform?
    The most current version of FDA regulations may be found at https://www.ecfr.gov. We request that comments be as specific as possible, 
include any supporting data or other information, such as cost 
information, provide a Code of Federal Regulations (CFR) citation when 
referencing a specific regulation, and provide specific suggestions 
regarding repeal, replacement, or modification. For comments relating 
to an information collection, cite to the approved information 
collection request and include the Office of Management and Budget 
(OMB) control number.
    In addition, in order to enable us to more efficiently review and 
consider comments, we ask that the comments be submitted in the format 
shown in table 1 of this document.

[[Page 42508]]



                 Table 1--Format for Submitting Comments
------------------------------------------------------------------------
           Name of regulation
------------------------------------------------------------------------
Type of product or FDA Center
 regulating the product.
Citation to Code of Federal Regulations
 and statutory citation (as
 applicable).
Approved information collection and OMB
 Control Number (as applicable).
Brief description of concern...........  (For example, what innovation
                                          makes the regulation outdated?
                                          Why?)
Available data on cost or economic       (Quantified costs and/or cost
 impact.                                  savings. Qualitative
                                          description, if needed.)
Proposed solution......................  (Include your solution. For
                                          example, how would you modify
                                          the regulation? Provide
                                          specific text if you are
                                          recommending a modification.)
------------------------------------------------------------------------

III. References

    The following references are on display in the Dockets Management 
Staff office (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Executive Order 13771 (January 30, 2017); available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs.
2. Executive Order 13777 (February 24, 2017); available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19047 Filed 9-7-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42507

SUPPLEMENTARY INFORMATION: that Act, in particular those regulations Agency and describe the way(s) in
that rely in whole or in part on data, which the regulations overlap, as well
I. Background
information, or methods that are not as any suggestions with respect to how
A. FDA’s Regulatory Mission publicly available or that are best to resolve the duplication.
FDA is responsible for protecting the insufficiently transparent to meet the • Have regulated entities had
public health by: (1) Ensuring the safety, standard for reproducibility; or difficulties complying with the
• Derive from or implement regulation? If yes, identify what entity
efficacy, and security of human and
Executive Orders or other Presidential or entities have had such difficulties
veterinary drugs, biological products,
directives that have been subsequently and the nature of the difficulties.
and medical devices; (2) ensuring the
rescinded or substantially modified.
safety, security, and appropriate • Does the regulation impose
labeling of our nation’s food supply, II. Request for Comments and requirements that are also provided for
products that emit radiation, and Information in voluntary or consensus standards or
cosmetics; and (3) regulating the To assist with our implementation of guidance by third party organizations
manufacture, marketing, and Executive Orders 13771 and 13777 and (e.g., International Council for
distribution of tobacco products. support the work of the RRTF of the Harmonisation, International
Equally important, FDA promotes the Department of Health and Human Organization for Standardization, Codex
public health by fostering and Services, FDA is issuing this Request for Alimentarius)? Do the entities covered
supporting innovative approaches and Information soliciting broad public by these standards or guidance take
solutions for some of our nation’s most comment on ways we can change our steps to meet the standards and to
compelling health and medical regulations to achieve meaningful document that they meet the standards?
challenges. burden reduction while continuing to If met, do the standards achieve the
This document is seeking comments achieve our public health mission and same level of public health protection as
and information solely on general fulfill statutory obligations. We request the FDA regulation? Are there entities
regulations and approved information comment, including supporting who are not covered by these standards
collections affecting multiple FDA technical, scientific, economic, or other or guidances or who choose not to
Centers and/or Offices. data, from all persons and entities observe them?
B. The Regulatory Reform Agenda: significantly affected by FDA • Does the regulation contain
Executive Orders 13771 and 13777 regulations, including consumers, redundant, outdated, or unnecessary
patients and caregivers, researchers, collections of information or retention
On January 30, 2017, President Trump healthcare institutions, the regulated of records, e.g., reporting,
issued Executive Order 13771, industry, trade associations, public recordkeeping, or labeling
‘‘Reducing Regulation and Controlling interest organizations, academia, and requirements? Explain in your response
Regulatory Costs’’ (Ref. 1). This State, local, and tribal governments, as why the information is redundant,
Executive Order states that the policy of well as any other interested stakeholder. outdated, or unnecessary.
the Executive Branch is to be prudent These comments and data will • Could the goal of the regulation be
and financially responsible in the supplement and inform our own achieved by less costly means that
expenditure of funds, from both public ongoing, systematic review of our would provide the same level of public
and private sources, and that it is regulations. health protection? If yes, provide
essential to manage the costs associated The following list of questions examples of alternatives that may
with complying with Federal includes those that FDA is using to reduce costs to industry while retaining
regulations. On February 24, 2017, guide our initial review of our the same level of public health
President Trump issued Executive regulations. This list is intended to help protection.
Order 13777, entitled ‘‘Enforcing the the public in providing comments, not • What factors should FDA consider
Regulatory Reform Agenda’’ (Ref. 2). The to restrict the issues that may be in selecting and prioritizing regulations
purpose of this Executive Order is to addressed. and reporting requirements for reform?
alleviate unnecessary regulatory • Is the regulation still current, or is
burdens placed on the American people. it outdated or unnecessary in some way? The most current version of FDA
Executive Order 13777 directs each Æ Have there been advancements and regulations may be found at https://
Agency to establish a Regulatory Reform innovations in science, technology, or www.ecfr.gov. We request that
Task Force (RRTF) to evaluate existing FDA or industry practice, or any other comments be as specific as possible,
regulations and identify those that may changes that suggest repeal of or include any supporting data or other
merit repeal, replacement, or modification to the regulation may be information, such as cost information,
modification. Section 3(d) of the warranted or appropriate? provide a Code of Federal Regulations
Executive Order provides that, at a Æ Has the regulation been superseded (CFR) citation when referencing a
minimum, each RRTF must attempt to or made irrelevant or unenforceable by specific regulation, and provide specific
identify regulations that: statute, another FDA regulation or suggestions regarding repeal,
• Eliminate jobs, or inhibit job guidance, a regulation by another replacement, or modification. For
creation; Federal Agency, or controlling legal comments relating to an information
• Are outdated, unnecessary, or authority? If yes, identify the statute, collection, cite to the approved
ineffective; regulation, guidance, or legal precedent information collection request and
sradovich on DSK3GMQ082PROD with PROPOSALS

• Impose costs that exceed benefits; and explain what FDA regulation is include the Office of Management and
• Create a serious inconsistency or affected and in what way it is affected. Budget (OMB) control number.
otherwise interfere with regulatory Æ Is this regulation duplicative of In addition, in order to enable us to
reform initiatives and policies; requirements in other FDA regulations more efficiently review and consider
• Are inconsistent with the or other Federal Agency regulations? If comments, we ask that the comments be
requirements of the Information Quality yes, identify the overlapping submitted in the format shown in table
Act, or the guidance issued pursuant to regulation(s) and responsible Federal 1 of this document.

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42508 Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules

TABLE 1—FORMAT FOR SUBMITTING COMMENTS
Name of regulation

Type of product or FDA Center regulating the product.
Citation to Code of Federal Regulations and statutory citation (as appli-
cable).
Approved information collection and OMB Control Number (as applica-
ble).
Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?)
Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if need-
ed.)
Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regula-
tion? Provide specific text if you are recommending a modification.)

III. References Condensable Particulate Emissions from hearing on our Web site at: https://
The following references are on Stationary Sources to improve the www.epa.gov/emc/emc-proposed-test-
display in the Dockets Management consistency in results achieved across methods. The EPA does not intend to
Staff office (see ADDRESSES) and are the testing community. publish another document in the
available for viewing by interested DATES: Federal Register announcing any
persons between 9 a.m. and 4 p.m., Comments. Comments must be updates on the request for a public
Monday through Friday; they are also received on or before November 7, 2017. hearing. Please contact Mr. Ned
available electronically at https:// Public Hearing. If a public hearing is Shappley at (919) 541–7903 or by email
www.regulations.gov. FDA has verified requested by September 18, 2017, then at shappley.ned@epa.gov to request a
the Web site addresses, as of the date we will hold a public hearing on public hearing, to register to speak at the
this document publishes in the Federal October 10, 2017 at the location public hearing, or to inquire as to
Register, but Web sites are subject to described in the ADDRESSES section. The whether a public hearing will be held.
change over time. last day to pre-register in advance to Docket: All documents in the docket
speak at the public hearing will be are listed in the http://
1. Executive Order 13771 (January 30, 2017); October 6, 2017.
available at https://
www.regulations.gov index. Although
www.federalregister.gov/documents/ ADDRESSES: Submit your comments, listed in the index, some information is
2017/02/03/2017-02451/reducing- identified by Docket ID No. EPA–HQ– not publicly available, e.g., CBI or other
regulation-and-controlling-regulatory- OAR–2016–0456, to the Federal information whose disclosure is
costs. eRulemaking Portal at http:// restricted by statute. Certain other
2. Executive Order 13777 (February 24, www.regulations.gov. Follow the online material, such as copyrighted material,
2017); available at https:// instructions for submitting comments. will be publicly available only in hard
www.federalregister.gov/documents/ Once submitted, comments cannot be copy. Publicly available docket
2017/03/01/2017-04107/enforcing-the- edited or withdrawn. The EPA may materials are available either
regulatory-reform-agenda.
publish any comment received to its electronically in http://
Dated: August 30, 2017. public docket. Do not submit www.regulations.gov or in hard copy at
Anna K. Abram, electronically any information you the EPA Docket Center, EPA/DC, EPA
Deputy Commissioner for Policy, Planning, consider to be Confidential Business WJC West Building, Room 3334, 1301
Legislation, and Analysis. Information (CBI) or other information Constitution Avenue NW., Washington,
[FR Doc. 2017–19047 Filed 9–7–17; 8:45 am] whose disclosure is restricted by statute. DC. This Docket Facility is open from
BILLING CODE 4164–01–P Multimedia submissions (audio, video, 8:30 a.m. to 4:30 p.m., Monday through
etc.) must be accompanied by a written Friday, excluding legal holidays. The
comment. The written comment is telephone number for the Public
ENVIRONMENTAL PROTECTION considered the official comment and Reading Room is (202) 566–1744, and
AGENCY should include discussion of all points the telephone number for the Air Docket
you wish to make. The EPA will is (202) 566–1742.
40 CFR Part 51 generally not consider comments or FOR FURTHER INFORMATION CONTACT: Mr.
[EPA–HQ–OAR–2016–0456; FRL–9966–75–
comment contents located outside of the Ned Shappley, Office of Air Quality
OAR] primary submission (i.e., on the Web, Planning and Standards, Air Quality
Cloud, or other file sharing system). For Assessment Division, Measurement
RIN 2060–AS91 additional submission methods, the full Technology Group (E143–02),
EPA public comment policy, Environmental Protection Agency,
Method 202—Dry Impinger Method for information about CBI or multimedia
Determining Condensable Particulate Research Triangle Park, NC 27711;
submissions, and general guidance on telephone number: (919) 541–5225; fax
Emissions From Stationary Sources making effective comments, please visit number: (919) 541–0516; email address:
http://www2.epa.gov/dockets/
sradovich on DSK3GMQ082PROD with PROPOSALS

AGENCY: Environmental Protection shappley.ned@epa.gov.
Agency (EPA). commenting-epa-dockets.
SUPPLEMENTARY INFORMATION: The
ACTION: Proposed rule. Public Hearing. If a public hearing is
requested, it will be held at EPA following topics are discussed in this
SUMMARY: In this action, the Headquarters, William Jefferson Clinton preamble.
Environmental Protection Agency (EPA) East Building, 1201 Constitution I. General Information
proposes editorial and technical Avenue NW., Washington, DC 20004. If A. Does this action apply to me?
revisions to the EPA’s Method 202—Dry a public hearing is requested, then we B. What should I consider as I prepare my
Impinger Method for Determining will provide details about the public comments?

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Document Created: 2018-10-24 14:09:29
Document Modified: 2018-10-24 14:09:29

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Request for comments and information.
Dates		Submit either electronic or written comments on this document by December 7, 2017.
Contact		Megan Velez, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, [email protected]
FR Citation		82 FR 42506

82 FR 42506 - Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 173 (September 8, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration