81_FR_84823 81 FR 84597 - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry; Availability

81 FR 84597 - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range84597-84598
FR Document2016-28122

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.

Federal Register, Volume 81 Issue 226 (Wednesday, November 23, 2016)
[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84597-84598]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28122]



[[Page 84597]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0558]


Contract Manufacturing Arrangements for Drugs: Quality 
Agreements; 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 ``Contract 
Manufacturing Arrangements for Drugs: Quality Agreements.'' This 
guidance describes FDA's current thinking on defining, establishing, 
and documenting manufacturing activities of the parties involved in 
contract drug manufacturing subject to current good manufacturing 
practice (CGMP) requirements. In particular, we describe how parties 
involved in contract drug manufacturing can use quality agreements to 
delineate their manufacturing activities to ensure compliance with 
CGMP.

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: 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): 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-2013-D-0558 for ``Contract Manufacturing Arrangements for Drugs: 
Quality Agreements.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://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 https://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/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Bldg., 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff, HFV-6, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. 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: Paula Katz, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4330, Silver Spring, MD 20993-0002, 301-796-6972; Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for 
Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 
Standish Pl., Rm. 130, Rockville, MD 20855, 240-402-5623.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Contract Manufacturing Arrangements for Drugs: Quality 
Agreements.'' This guidance describes FDA's current thinking on 
defining, establishing, and documenting manufacturing activities of the 
parties involved in contract drug manufacturing subject to CGMP 
requirements. Owners and contract facilities can draw on quality 
management principles to carry out the complicated process of contract 
drug manufacturing by defining, establishing, and documenting their 
activities for ensuring compliance with CGMP and to ensure the quality, 
safety, and effectiveness of drugs.

[[Page 84598]]

    This guidance replaces the draft guidance of the same name that 
published in the Federal Register of May 28, 2013 (78 FR 31943). We 
have carefully reviewed and considered the comments that were received 
on the draft guidance and have made changes for clarification. In 
particular, our revisions clarified the scope and applicability of the 
guidance and key terms used in the guidance.
    Regarding scope and applicability, we have clarified that the 
guidance is limited to commercial manufacturing activities. Although 
the principles articulated may be useful in approaching quality 
agreements for other kinds of activities, such as clinical research, 
development, or distribution, these are outside the scope of this 
particular document.
    Many comments concerned the terms ``owner'' and ``contract 
facility.'' Although some comments recommended that this guidance adopt 
the terms ``contract giver'' and ``contract acceptor,'' these terms do 
not align with our goal of showing how the parties to a contract 
manufacturing arrangement can work together to define, establish, and 
document agreements that delineate manufacturing activities and ensure 
compliance with CGMP.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Contract Manufacturing Arrangements for 
Drugs: Quality Agreements. It 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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and 
have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov/.

    Dated: November 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28122 Filed 11-22-16; 8:45 am]
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                                                                          Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices                                          84597

                                                  DEPARTMENT OF HEALTH AND                                Written/Paper Submissions                             received, go to https://
                                                  HUMAN SERVICES                                             Submit written/paper submissions as                www.regulations.gov/ and insert the
                                                                                                          follows:                                              docket number, found in brackets in the
                                                  Food and Drug Administration                               • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                                                                                          written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                                  [Docket No. FDA–2013–D–0558]
                                                                                                          Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                  Contract Manufacturing Arrangements                     and Drug Administration, 5630 Fishers                 Management, 5630 Fishers Lane, Rm.
                                                  for Drugs: Quality Agreements;                          Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                  Guidance for Industry; Availability                        • For written/paper comments                          Submit written requests for single
                                                                                                          submitted to the Division of Dockets                  copies of this guidance to the Division
                                                  AGENCY:    Food and Drug Administration,                Management, FDA will post your                        of Drug Information, Center for Drug
                                                  HHS.                                                    comment, as well as any attachments,                  Evaluation and Research, Food and
                                                  ACTION:   Notice of availability.                       except for information submitted,                     Drug Administration, 10001 New
                                                                                                          marked and identified, as confidential,               Hampshire Ave., Hillandale Bldg., 4th
                                                  SUMMARY:   The Food and Drug                            if submitted as detailed in                           Floor, Silver Spring, MD 20993–0002;
                                                  Administration (FDA or Agency) is                       ‘‘Instructions.’’                                     the Office of Communication, Outreach
                                                  announcing the availability of a                           Instructions: All submissions received             and Development, Center for Biologics
                                                  guidance for industry entitled ‘‘Contract               must include the Docket No. FDA–                      Evaluation and Research, Food and
                                                  Manufacturing Arrangements for Drugs:                   2013–D–0558 for ‘‘Contract                            Drug Administration, 10903 New
                                                  Quality Agreements.’’ This guidance                     Manufacturing Arrangements for Drugs:                 Hampshire Ave., Bldg. 71, Rm. 3128,
                                                  describes FDA’s current thinking on                     Quality Agreements.’’ Received                        Silver Spring, MD 20993–0002; or the
                                                  defining, establishing, and documenting                 comments will be placed in the docket                 Policy and Regulations Staff, HFV–6,
                                                  manufacturing activities of the parties                 and, except for those submitted as                    Center for Veterinary Medicine, Food
                                                  involved in contract drug manufacturing                 ‘‘Confidential Submissions,’’ publicly                and Drug Administration, 7519 Standish
                                                  subject to current good manufacturing                   viewable at https://                                  Pl., Rockville, MD 20855. Send one self-
                                                  practice (CGMP) requirements. In                        www.regulations.gov/ or at the Division               addressed adhesive label to assist that
                                                  particular, we describe how parties                     of Dockets Management between 9 a.m.                  office in processing your requests. See
                                                  involved in contract drug manufacturing                 and 4 p.m., Monday through Friday.                    the SUPPLEMENTARY INFORMATION section
                                                  can use quality agreements to delineate                    • Confidential Submissions—To                      for electronic access to the guidance
                                                  their manufacturing activities to ensure                submit a comment with confidential                    document.
                                                  compliance with CGMP.                                   information that you do not wish to be
                                                  DATES: Submit either electronic or                                                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                          made publicly available submit your
                                                  written comments on Agency guidances                                                                          Paula Katz, Center for Drug Evaluation
                                                                                                          comments only as a written/paper
                                                  at any time.                                                                                                  and Research, Food and Drug
                                                                                                          submission. You should submit two
                                                                                                                                                                Administration, 10903 New Hampshire
                                                  ADDRESSES: You may submit comments                      copies total. One copy will include the
                                                                                                                                                                Ave., Bldg. 51, Rm. 4330, Silver Spring,
                                                  as follows:                                             information you claim to be confidential
                                                                                                                                                                MD 20993–0002, 301–796–6972;
                                                                                                          with a heading or cover note that states
                                                  Electronic Submissions                                                                                        Stephen Ripley, Center for Biologics
                                                                                                          ‘‘THIS DOCUMENT CONTAINS
                                                    Submit electronic comments in the                                                                           Evaluation and Research, Food and
                                                                                                          CONFIDENTIAL INFORMATION.’’ The
                                                  following way:                                                                                                Drug Administration, 10903 New
                                                                                                          Agency will review this copy, including
                                                    • Federal eRulemaking Portal:                                                                               Hampshire Ave., Bldg. 71, Rm. 7301,
                                                                                                          the claimed confidential information, in
                                                  https://www.regulations.gov. Follow the                                                                       Silver Spring, MD 20993–0002, 240–
                                                                                                          its consideration of comments. The
                                                  instructions for submitting comments.                                                                         402–7911; or Jonathan Bray, Center for
                                                                                                          second copy, which will have the
                                                  Comments submitted electronically,                                                                            Veterinary Medicine (HFV–232), Food
                                                                                                          claimed confidential information
                                                  including attachments, to https://                                                                            and Drug Administration, 7519 Standish
                                                                                                          redacted/blacked out, will be available
                                                  www.regulations.gov will be posted to                                                                         Pl., Rm. 130, Rockville, MD 20855, 240–
                                                                                                          for public viewing and posted on
                                                  the docket unchanged. Because your                                                                            402–5623.
                                                                                                          https://www.regulations.gov/. Submit
                                                  comment will be made public, you are                    both copies to the Division of Dockets                SUPPLEMENTARY INFORMATION:
                                                  solely responsible for ensuring that your               Management. If you do not wish your                   I. Background
                                                  comment does not include any                            name and contact information to be
                                                  confidential information that you or a                  made publicly available, you can                         FDA is announcing the availability of
                                                  third party may not wish to be posted,                  provide this information on the cover                 a guidance for industry entitled
                                                  such as medical information, your or                    sheet and not in the body of your                     ‘‘Contract Manufacturing Arrangements
                                                  anyone else’s Social Security number, or                comments and you must identify this                   for Drugs: Quality Agreements.’’ This
                                                  confidential business information, such                 information as ‘‘confidential.’’ Any                  guidance describes FDA’s current
                                                  as a manufacturing process. Please note                 information marked as ‘‘confidential’’                thinking on defining, establishing, and
                                                  that if you include your name, contact                  will not be disclosed except in                       documenting manufacturing activities of
                                                  information, or other information that                  accordance with 21 CFR 10.20 and other                the parties involved in contract drug
                                                  identifies you in the body of your                      applicable disclosure law. For more                   manufacturing subject to CGMP
                                                  comments, that information will be                      information about FDA’s posting of                    requirements. Owners and contract
                                                  posted on https://www.regulations.gov/.                 comments to public dockets, see 80 FR                 facilities can draw on quality
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                                                    • If you want to submit a comment                     56469, September 18, 2015, or access                  management principles to carry out the
                                                  with confidential information that you                  the information at: http://www.fda.gov/               complicated process of contract drug
                                                  do not wish to be made available to the                 regulatoryinformation/dockets/                        manufacturing by defining, establishing,
                                                  public, submit the comment as a                         default.htm.                                          and documenting their activities for
                                                  written/paper submission and in the                        Docket: For access to the docket to                ensuring compliance with CGMP and to
                                                  manner detailed (see ‘‘Written/Paper                    read background documents or the                      ensure the quality, safety, and
                                                  Submissions’’ and ‘‘Instructions’’).                    electronic and written/paper comments                 effectiveness of drugs.


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                                                  84598                   Federal Register / Vol. 81, No. 226 / Wednesday, November 23, 2016 / Notices

                                                     This guidance replaces the draft                     GuidanceforIndustry/default.htm, or                   DEPARTMENT OF HEALTH AND
                                                  guidance of the same name that                          https://www.regulations.gov/.                         HUMAN SERVICES
                                                  published in the Federal Register of                      Dated: November 17, 2016.
                                                  May 28, 2013 (78 FR 31943). We have                                                                           National Institutes of Health
                                                  carefully reviewed and considered the                   Leslie Kux,
                                                  comments that were received on the                      Associate Commissioner for Policy.                    National Institute of Diabetes and
                                                  draft guidance and have made changes                    [FR Doc. 2016–28122 Filed 11–22–16; 8:45 am]          Digestive and Kidney Diseases: Notice
                                                  for clarification. In particular, our                   BILLING CODE 4164–01–P
                                                                                                                                                                of Closed Meetings
                                                  revisions clarified the scope and                                                                               Pursuant to section 10(d) of the
                                                  applicability of the guidance and key                                                                         Federal Advisory Committee Act, as
                                                  terms used in the guidance.                             DEPARTMENT OF HEALTH AND                              amended (5 U.S.C. App.), notice is
                                                     Regarding scope and applicability, we                HUMAN SERVICES                                        hereby given of the following meetings.
                                                  have clarified that the guidance is                                                                             The meetings will be closed to the
                                                  limited to commercial manufacturing                     National Institutes of Health                         public in accordance with the
                                                  activities. Although the principles                                                                           provisions set forth in sections
                                                  articulated may be useful in                            National Cancer Institute Amended                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                  approaching quality agreements for                      Notice of Meeting                                     as amended. The grant applications and
                                                  other kinds of activities, such as clinical                                                                   the discussions could disclose
                                                  research, development, or distribution,                    Notice is hereby given of a change in              confidential trade secrets or commercial
                                                  these are outside the scope of this                     the meeting of the Joint Board meeting                property such as patentable material,
                                                  particular document.                                    of the National Cancer Advisory Board                 and personal information concerning
                                                     Many comments concerned the terms                    and NCI Board of Scientific Advisors,                 individuals associated with the grant
                                                  ‘‘owner’’ and ‘‘contract facility.’’                    December 5, 2016, 4:30 p.m. to                        applications, the disclosure of which
                                                  Although some comments                                  December 7, 2016, 12:00 p.m., National                would constitute a clearly unwarranted
                                                  recommended that this guidance adopt                    Cancer Institute Shady Grove, Shady                   invasion of personal privacy.
                                                  the terms ‘‘contract giver’’ and ‘‘contract             Grove, 9609 Medical Center Drive,
                                                  acceptor,’’ these terms do not align with                                                                       Name of Committee: National Institute of
                                                                                                          7W116, Rockville, MD 20850 which was                  Diabetes and Digestive and Kidney Diseases
                                                  our goal of showing how the parties to                  published in the Federal Register on                  Special Emphasis Panel; NIDDK DDK–B
                                                  a contract manufacturing arrangement
                                                                                                          October 31, 2016, 81 FR 75423.                        Member, Conflict Application Review.
                                                  can work together to define, establish,                                                                         Date: December 5, 2016.
                                                  and document agreements that delineate                     The meeting notice is amended to                     Time: 11:00 a.m. to 12:00 p.m.
                                                  manufacturing activities and ensure                     change the date, time and location of the               Agenda: To review and evaluate grant
                                                  compliance with CGMP.                                   meeting and to cancel the Ad Hoc                      applications.
                                                     This guidance is being issued                        Subcommittee on Global Cancer                           Place: National Institutes of Health, Two
                                                  consistent with FDA’s good guidance                     Research on December 5, 2016. There                   Democracy Plaza, 6707 Democracy
                                                  practices regulation (21 CFR 10.115).                   will be a National Cancer Advisory                    Boulevard, Bethesda, MD 20892, (Telephone
                                                                                                                                                                Conference Call).
                                                  The guidance represents the current                     Board Ad hoc Subcommittee on Clinical                   Contact Person: Carol J. Goter-Robinson,
                                                  thinking of FDA on Contract                             Investigations on December 5, 2016,                   Ph.D., Scientific Review Officer, Review
                                                  Manufacturing Arrangements for Drugs:                   from 6:00 p.m. to 7:30 p.m. at the Pooks              Branch, DEA, NIDDK, National Institutes of
                                                  Quality Agreements. It does not                         Hill Marriott Hotel, Annapolis and                    Health, Room 7347, 6707 Democracy
                                                  establish any rights for any person and                 Chesapeake Room, 5151 Pooks Hill                      Boulevard, Bethesda, MD 20892–5452, (301)
                                                  is not binding on FDA or the public.                    Road, Bethesda, MD 20814. The Joint                   594–7791, goterrobinsonc@
                                                  You can use an alternative approach if                                                                        extra.niddk.nih.gov.
                                                                                                          meeting of the National Cancer
                                                  it satisfies the requirements of the                                                                            This notice is being published less than 15
                                                                                                          Advisory Board and NCI Board of                       days prior to the meeting due to the timing
                                                  applicable statutes and regulations.                    Scientific Advisors will now be held on               limitations imposed by the review and
                                                  II. The Paperwork Reduction Act of                      December 6, 2016 at the National                      funding cycle.
                                                  1995                                                    Institutes of Health, Building 31,                      Name of Committee: National Institute of
                                                     This guidance refers to previously                   Conference Room 10, 31 Center Drive,                  Diabetes and Digestive and Kidney Diseases
                                                  approved collections of information                     Bethesda, MD 20892. The open session                  Special Emphasis Panel; PAR 14–301: NIDDK
                                                                                                          is from 8:30 a.m. to 3:45 p.m. The closed             Central Repositories Sample Access (X01).
                                                  found in FDA regulations. These
                                                                                                          session will begin at 4:00 p.m. and end                 Date: January 18, 2017.
                                                  collections of information are subject to                                                                       Time: 11:00 a.m. to 2:00 p.m.
                                                  review by the Office of Management and                  at 5:00 p.m. The meeting is partially                   Agenda: To review and evaluate grant
                                                  Budget (OMB) under the Paperwork                        closed to the public.                                 applications.
                                                  Reduction Act of 1995 (44 U.S.C. 3501–                    Dated: November 17, 2016.                             Place: National Institutes of Health, Two
                                                  3520) and have been approved under                                                                            Democracy Plaza, 6707 Democracy
                                                                                                          Melanie J. Pantoja,
                                                  OMB control number 0910–0139.                                                                                 Boulevard, Bethesda, MD 20892, (Telephone
                                                                                                          Program Analyst, Office of Federal Advisory           Conference Call).
                                                  III. Electronic Access                                  Committee Policy.                                       Contact Person: Najma Begum, Ph.D.,
                                                     Persons with access to the Internet                  [FR Doc. 2016–28146 Filed 11–22–16; 8:45 am]          Scientific Review Officer, Review Branch,
                                                  may obtain the document at either                       BILLING CODE 4140–01–P
                                                                                                                                                                DEA, NIDDK, National Institutes of Health,
                                                                                                                                                                Room 7349, 6707 Democracy Boulevard,
                                                  http://www.fda.gov/Drugs/Guidance
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                                                                                                                                                                Bethesda, MD 20892–5452, (301) 594–8894,
                                                  ComplianceRegulatoryInformation/                                                                              begumn@niddk.nih.gov.
                                                  Guidances/default.htm, http://
                                                                                                                                                                  Name of Committee: National Institute of
                                                  www.fda.gov/BiologicsBloodVaccines/                                                                           Diabetes and Digestive and Kidney Diseases
                                                  GuidanceComplianceRegulatory                                                                                  Special Emphasis Panel; PAR–15–067: U01
                                                  Information/Guidances/default.htm,                                                                            Applications.
                                                  http://www.fda.gov/AnimalVeterinary/                                                                            Date: January 24, 2017.
                                                  GuidanceComplianceEnforcement/                                                                                  Time: 11:00 a.m. to 12:30 p.m.



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Document Created: 2016-11-23 05:29:37
Document Modified: 2016-11-23 05:29:37
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.
ContactPaula Katz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4330, Silver Spring, MD 20993-0002, 301-796-6972; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Pl., Rm. 130, Rockville, MD 20855, 240-402-5623.
FR Citation81 FR 84597 

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