81_FR_84820 81 FR 84594 - Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability

81 FR 84594 - Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 226 (November 23, 2016)

Page Range84594-84595
FR Document2016-28124

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Safety and Effectiveness Data.'' This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.

Federal Register, Volume 81 Issue 226 (Wednesday, November 23, 2016)
[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84594-84595]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28124]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4021]


Nonprescription Sunscreen Drug Products--Safety and Effectiveness 
Data; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Nonprescription 
Sunscreen Drug Products--Safety and Effectiveness Data.'' This guidance 
addresses FDA's current thinking on the safety and effectiveness data 
needed to determine whether a nonprescription sunscreen active 
ingredient or combination of active ingredients evaluated under the 
Sunscreen Innovation Act (SIA) is generally recognized as safe and 
effective (GRASE) and not misbranded when used under specified 
conditions. The guidance also addresses FDA's current thinking about an 
approach to safety-related final formulation testing that the Agency 
anticipates adopting in the future.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-4021 for ``Nonprescription Sunscreen Drug Products--Safety 
and Effectiveness Data; Guidance for Industry; Availability.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatory&information/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5443, Silver Spring, MD 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nonprescription Sunscreen Drug Products--Safety and 
Effectiveness Data.'' This guidance replaces a draft

[[Page 84595]]

guidance entitled ``Over-the-Counter Sunscreens: Safety and 
Effectiveness Data'' that was issued on November 23, 2015 (see 80 FR 
72975) and incorporates editorial changes and clarifying language based 
on FDA's consideration of comments received on that draft guidance. The 
draft guidance and related public comments are available at http://www.regulations.gov by searching Docket No. FDA-2015-D-4021.
    This guidance addresses the current thinking of FDA about the 
safety and effectiveness data needed to determine whether a 
nonprescription sunscreen active ingredient or combination of active 
ingredients evaluated under the SIA (Pub. L. 113-195), enacted November 
26, 2014, which amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 351 et seq.), is GRASE and not misbranded when 
used under specified conditions. The guidance also addresses FDA's 
current thinking about an approach to safety-related final formulation 
testing that it anticipates adopting in the future. FDA is issuing this 
guidance in partial implementation of the SIA which, among other 
things, established new procedures and review timelines for FDA to 
determine whether a nonprescription sunscreen active ingredient or 
combination of active ingredients is GRASE and not misbranded when used 
under the conditions specified in a final sunscreen order, in 
accordance with sections 586A, 586B, and 586C of the FD&C Act (21 
U.S.C. 360fff-1, 360fff-2, and 360fff-3). The SIA directed FDA to issue 
guidance on four topics, including guidance regarding safety and 
effectiveness data in accordance with section 586D of the FD&C Act (21 
U.S.C. 360ffff-4). Many of the safety topics addressed in this guidance 
were discussed at a public Nonprescription Drug Advisory Committee 
meeting held on September 4 and 5, 2014, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on the topics it addresses. This guidance does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains collections of information that are exempt 
from the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Section 586D(a)(1)(C) of the FD&C Act, as amended by the SIA, 
states that the PRA shall not apply to collections of information made 
for purposes of guidance under that subsection.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28124 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                  84594                    Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices

                                                  II. The Paperwork Reduction Act of                      Electronic Submissions                                information you claim to be confidential
                                                  1995                                                      Submit electronic comments in the                   with a heading or cover note that states
                                                    This guidance contains collections of                 following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  information that are exempt from the                      • Federal eRulemaking Portal: http://               CONFIDENTIAL INFORMATION.’’ The
                                                  Paperwork Reduction Act of 1995 (the                    www.regulations.gov. Follow the                       Agency will review this copy, including
                                                  PRA) (44 U.S.C. 3501–3520). Section                     instructions for submitting comments.                 the claimed confidential information, in
                                                  586D(a)(1)(C) of the FD&C Act, as                       Comments submitted electronically,                    its consideration of comments. The
                                                  amended by the SIA, states that the PRA                 including attachments, to http://                     second copy, which will have the
                                                  shall not apply to collections of                       www.regulations.gov will be posted to                 claimed confidential information
                                                  information for purposes of guidance                    the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  under that subsection.                                  comment will be made public, you are                  for public viewing and posted on http://
                                                                                                          solely responsible for ensuring that your             www.regulations.gov. Submit both
                                                  III. Electronic Access                                                                                        copies to the Division of Dockets
                                                                                                          comment does not include any
                                                    Persons with access to the Internet                   confidential information that you or a                Management. If you do not wish your
                                                  may obtain the document at either                       third party may not wish to be posted,                name and contact information to be
                                                  http://www.fda.gov/Drugs/Guidance                       such as medical information, your or                  made publicly available, you can
                                                  ComplianceRegulatoryInformation/                        anyone else’s Social Security number, or              provide this information on the cover
                                                  Guidances/default.htm or http://                        confidential business information, such               sheet and not in the body of your
                                                  www.regulations.gov.                                    as a manufacturing process. Please note               comments and you must identify this
                                                                                                          that if you include your name, contact                information as ‘‘confidential.’’ Any
                                                    Dated: November 17, 2016.                                                                                   information marked as ‘‘confidential’’
                                                  Leslie Kux,                                             information, or other information that
                                                                                                          identifies you in the body of your                    will not be disclosed except in
                                                  Associate Commissioner for Policy.                                                                            accordance with 21 CFR 10.20 and other
                                                                                                          comments, that information will be
                                                  [FR Doc. 2016–28121 Filed 11–22–16; 8:45 am]
                                                                                                          posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                  BILLING CODE 4164–01–P
                                                                                                            • If you want to submit a comment                   information about FDA’s posting of
                                                                                                          with confidential information that you                comments to public dockets, see 80 FR
                                                                                                          do not wish to be made available to the               56469, September 18, 2015, or access
                                                  DEPARTMENT OF HEALTH AND                                                                                      the information at: http://www.fda.gov/
                                                                                                          public, submit the comment as a
                                                  HUMAN SERVICES                                                                                                regulatory&information/dockets/
                                                                                                          written/paper submission and in the
                                                                                                          manner detailed (see ‘‘Written/Paper                  default.htm.
                                                  Food and Drug Administration                                                                                     Docket: For access to the docket to
                                                                                                          Submissions’’ and ‘‘Instructions’’).
                                                                                                                                                                read background documents or the
                                                  [Docket No. FDA–2015–D–4021]                            Written/Paper Submissions                             electronic and written/paper comments
                                                  Nonprescription Sunscreen Drug                             Submit written/paper submissions as                received, go to http://
                                                  Products—Safety and Effectiveness                       follows:                                              www.regulations.gov and insert the
                                                  Data; Guidance for Industry;                               • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                  Availability                                            written/paper submissions): Division of               heading of this document, into the
                                                                                                          Dockets Management (HFA–305), Food                    ‘‘Search’’ box and follow the prompts
                                                  AGENCY:    Food and Drug Administration,                and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                                  HHS.                                                    Lane, Rm. 1061, Rockville, MD 20852.                  Management, 5630 Fishers Lane, Rm.
                                                  ACTION:   Notice of availability.                          • For written/paper comments                       1061, Rockville, MD 20852.
                                                                                                          submitted to the Division of Dockets                     Submit written requests for single
                                                  SUMMARY:   The Food and Drug                            Management, FDA will post your                        copies of the guidance to the Division of
                                                  Administration (FDA or Agency) is                       comment, as well as any attachments,                  Drug Information, Center for Drug
                                                  announcing the availability of a                        except for information submitted,                     Evaluation and Research, Food and
                                                  guidance for industry entitled                          marked and identified, as confidential,               Drug Administration, 10001 New
                                                  ‘‘Nonprescription Sunscreen Drug                        if submitted as detailed in                           Hampshire Ave., Hillandale Building,
                                                  Products—Safety and Effectiveness                       ‘‘Instructions.’’                                     4th Floor, Silver Spring, MD 20993–
                                                  Data.’’ This guidance addresses FDA’s                      Instructions: All submissions received             0002. Send one self-addressed adhesive
                                                  current thinking on the safety and                      must include the Docket No. FDA–                      label to assist that office in processing
                                                  effectiveness data needed to determine                  2015–D–4021 for ‘‘Nonprescription                     your requests. See the SUPPLEMENTARY
                                                  whether a nonprescription sunscreen                     Sunscreen Drug Products—Safety and                    INFORMATION section for electronic
                                                  active ingredient or combination of                     Effectiveness Data; Guidance for                      access to the guidance document.
                                                  active ingredients evaluated under the                  Industry; Availability.’’ Received                    FOR FURTHER INFORMATION CONTACT:
                                                  Sunscreen Innovation Act (SIA) is                       comments will be placed in the docket                 Kristen Hardin, Center for Drug
                                                  generally recognized as safe and                        and, except for those submitted as                    Evaluation and Research, Food and
                                                  effective (GRASE) and not misbranded                    ‘‘Confidential Submissions,’’ publicly                Drug Administration, 10903 New
                                                  when used under specified conditions.                   viewable at http://www.regulations.gov                Hampshire Ave., Bldg. 22, rm. 5443,
                                                  The guidance also addresses FDA’s                       or at the Division of Dockets                         Silver Spring, MD 20993–0002, 240–
                                                  current thinking about an approach to                   Management between 9 a.m. and 4 p.m.,                 402–4246.
                                                  safety-related final formulation testing                Monday through Friday.
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                SUPPLEMENTARY INFORMATION:
                                                  that the Agency anticipates adopting in                    • Confidential Submissions—To
                                                  the future.                                             submit a comment with confidential                    I. Background
                                                  DATES: Submit either electronic or                      information that you do not wish to be                   FDA is announcing the availability of
                                                  written comments on Agency guidances                    made publicly available, submit your                  a guidance for industry entitled
                                                  at any time.                                            comments only as a written/paper                      ‘‘Nonprescription Sunscreen Drug
                                                  ADDRESSES: You may submit comments                      submission. You should submit two                     Products—Safety and Effectiveness
                                                  as follows:                                             copies total. One copy will include the               Data.’’ This guidance replaces a draft


                                             VerDate Sep<11>2014   18:04 Nov 22, 2016   Jkt 241001   PO 00000   Frm 00048   Fmt 4703   Sfmt 4703   E:\FR\FM\23NON1.SGM   23NON1


                                                                          Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices                                            84595

                                                  guidance entitled ‘‘Over-the-Counter                    II. The Paperwork Reduction Act of                     Electronic Submissions
                                                  Sunscreens: Safety and Effectiveness                    1995                                                     Submit electronic scientific data,
                                                  Data’’ that was issued on November 23,                                                                         information, and comments in the
                                                  2015 (see 80 FR 72975) and incorporates                   This guidance contains collections of
                                                                                                          information that are exempt from the                   following way:
                                                  editorial changes and clarifying
                                                                                                          Paperwork Reduction Act of 1995 (the                     • Federal eRulemaking Portal: http://
                                                  language based on FDA’s consideration                                                                          www.regulations.gov. Follow the
                                                                                                          PRA) (44 U.S.C. 3501–3520). Section
                                                  of comments received on that draft                                                                             instructions for submitting comments.
                                                                                                          586D(a)(1)(C) of the FD&C Act, as
                                                  guidance. The draft guidance and                                                                               Comments submitted electronically,
                                                                                                          amended by the SIA, states that the PRA
                                                  related public comments are available at                shall not apply to collections of                      including attachments, to http://
                                                  http://www.regulations.gov by searching                 information made for purposes of                       www.regulations.gov will be posted to
                                                  Docket No. FDA–2015–D–4021.                             guidance under that subsection.                        the docket unchanged. Because your
                                                     This guidance addresses the current                                                                         comments will be made public, you are
                                                                                                          III. Electronic Access                                 solely responsible for ensuring that your
                                                  thinking of FDA about the safety and
                                                  effectiveness data needed to determine                                                                         comment does not include any
                                                                                                            Persons with access to the Internet                  confidential information that you or a
                                                  whether a nonprescription sunscreen                     may obtain the guidance at either http://              third party may not wish to be posted,
                                                  active ingredient or combination of                     www.fda.gov/Drugs/Guidance                             such as medical information, your or
                                                  active ingredients evaluated under the                  ComplianceRegulatoryInformation/                       anyone else’s Social Security number, or
                                                  SIA (Pub. L. 113–195), enacted                          Guidances/default.htm or http://                       confidential business information, such
                                                  November 26, 2014, which amended the                    www.regulations.gov.                                   as a manufacturing process. Please note
                                                  Federal Food, Drug, and Cosmetic Act                      Dated: November 17, 2016.                            that if you include your name, contact
                                                  (the FD&C Act) (21 U.S.C. 351 et seq.),                 Leslie Kux,                                            information, or other information that
                                                  is GRASE and not misbranded when                                                                               identifies you in the body of your
                                                                                                          Associate Commissioner for Policy.
                                                  used under specified conditions. The                                                                           comments, that information will be
                                                                                                          [FR Doc. 2016–28124 Filed 11–22–16; 8:45 am]
                                                  guidance also addresses FDA’s current                                                                          posted on http://www.regulations.gov.
                                                                                                          BILLING CODE 4164–01–P
                                                  thinking about an approach to safety-                                                                            • If you want to submit a comment
                                                  related final formulation testing that it                                                                      with confidential information that you
                                                  anticipates adopting in the future. FDA                 DEPARTMENT OF HEALTH AND                               do not wish to be made available to the
                                                  is issuing this guidance in partial                     HUMAN SERVICES                                         public, submit the comment as a
                                                  implementation of the SIA which,                                                                               written/paper submission and in the
                                                  among other things, established new                     Food and Drug Administration                           manner detailed (see ‘‘Written/Paper
                                                  procedures and review timelines for                                                                            Submissions’’ and ‘‘Instructions’’).
                                                  FDA to determine whether a                              [Docket No. FDA–2016–N–3389]                           Written/Paper Submissions
                                                  nonprescription sunscreen active
                                                  ingredient or combination of active                     Evaluation of the Beneficial                              Submit written/paper submissions as
                                                  ingredients is GRASE and not                            Physiological Effects of Isolated or                   follows:
                                                                                                          Synthetic Non-Digestible                                  • Mail/Hand delivery/Courier (for
                                                  misbranded when used under the
                                                                                                          Carbohydrates; Request for Scientific                  written/paper submissions): Division of
                                                  conditions specified in a final sunscreen
                                                                                                          Data, Information, and Comments                        Dockets Management (HFA–305), Food
                                                  order, in accordance with sections
                                                                                                                                                                 and Drug Administration, 5630 Fishers
                                                  586A, 586B, and 586C of the FD&C Act                                                                           Lane, Rm. 1061, Rockville, MD 20852.
                                                  (21 U.S.C. 360fff–1, 360fff–2, and                      AGENCY:    Food and Drug Administration,
                                                                                                          HHS.                                                      • For written/paper comments
                                                  360fff–3). The SIA directed FDA to issue                                                                       submitted to the Division of Dockets
                                                  guidance on four topics, including                      ACTION:  Notice; request for scientific                Management, FDA will post your
                                                  guidance regarding safety and                           data, information, and comments.                       comment, as well as any attachments,
                                                  effectiveness data in accordance with                                                                          except for information submitted,
                                                  section 586D of the FD&C Act (21 U.S.C.                 SUMMARY:    The Food and Drug                          marked and identified, as confidential,
                                                  360ffff–4). Many of the safety topics                   Administration (FDA or we) is                          if submitted as detailed in
                                                  addressed in this guidance were                         requesting scientific data, information,               ‘‘Instructions.’’
                                                  discussed at a public Nonprescription                   and comments that would help us                           Instructions: All submissions received
                                                  Drug Advisory Committee meeting held                    evaluate the beneficial physiological                  must include the Docket No. FDA–
                                                  on September 4 and 5, 2014, http://                     effects to human health of isolated or                 2016–N–3389 for ‘‘Evaluation of the
                                                  www.fda.gov/AdvisoryCommittees/                         synthetic non-digestible carbohydrates                 Beneficial Physiological Effects of
                                                  CommitteesMeetingMaterials/Drugs/                       that are added to foods. We are                        Isolated or Synthetic Non-Digestible
                                                  NonprescriptionDrugsAdvisory                            requesting such scientific data,                       Carbohydrates; Request for Scientific
                                                  Committee/ucm380890.htm.                                information, and comments to help us                   Data, Information, and Comments.’’
                                                                                                          determine whether a particular isolated                Received comments will be placed in
                                                     This guidance is being issued                        or synthetic non-digestible carbohydrate               the docket and, except for those
                                                  consistent with FDA’s good guidance                     should be added to our definition of                   submitted as ‘‘Confidential
                                                  practices regulation (21 CFR 10.115).                   ‘‘dietary fiber’’ for purposes of being                Submissions,’’ publicly viewable at
                                                  The guidance represents FDA’s current                   declared as dietary fiber on a Nutrition               http://www.regulations.gov or at the
mstockstill on DSK3G9T082PROD with NOTICES




                                                  thinking on the topics it addresses. This               Facts or Supplement Facts label.                       Division of Dockets Management
                                                  guidance does not establish any rights                                                                         between 9 a.m. and 4 p.m., Monday
                                                  for any person and is not binding on                    DATES: Submit either electronic or
                                                                                                                                                                 through Friday.
                                                                                                          written scientific data, information, and
                                                  FDA or the public. You can use an                                                                                 • Confidential Submissions—To
                                                  alternative approach if it satisfies the                comments by January 9, 2017.
                                                                                                                                                                 submit a comment with confidential
                                                  requirements of the applicable statutes                 ADDRESSES:        You may submit comments              information that you do not wish to be
                                                  and regulations.                                        as follows:                                            made publicly available, submit your


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Document Created: 2016-11-23 05:30:32
Document Modified: 2016-11-23 05:30:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactKristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5443, Silver Spring, MD 20993-0002, 240- 402-4246.
FR Citation81 FR 84594 

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