81_FR_41668 81 FR 41545 - Quality Metrics Technical Conformance Guide-Technical Specifications Document; Availability

81 FR 41545 - Quality Metrics Technical Conformance Guide-Technical Specifications Document; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 123 (June 27, 2016)

Page Range41545-41546
FR Document2016-15099

The Food and Drug Administration (FDA or Agency) is announcing the availability of a Technical Specifications Document entitled ``Quality Metrics Technical Conformance Guide, Version 1.0.'' This Guide provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry, when finalized, on ``Request for Quality Metrics,'' dated July 28, 2015.

Federal Register, Volume 81 Issue 123 (Monday, June 27, 2016)
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41545-41546]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15099]



[[Page 41545]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1594]


Quality Metrics Technical Conformance Guide--Technical 
Specifications Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a Technical Specifications Document entitled 
``Quality Metrics Technical Conformance Guide, Version 1.0.'' This 
Guide provides technical recommendations for the submission of quality 
metric data. It serves as the technical reference for implementation of 
the draft FDA guidance for industry, when finalized, on ``Request for 
Quality Metrics,'' dated July 28, 2015.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 26, 2016.

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-2016-D-1594 for ``Quality Metrics Technical Conformance Guide--
Technical Specifications Document.'' 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/regulatoryinformation/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 draft guide to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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 draft guidance document. All comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 
[email protected], 301-796-3257; or 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a Technical Specifications 
Document for industry entitled ``Quality Metrics Technical Conformance 
Guide, Version 1.0.'' This Guide supplements the draft FDA guidance for 
industry on ``Request for Quality Metrics,'' available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455957.pdf, and provides recommendations about submission 
of records and other information that will support FDA's calculation of 
quality metrics as part of the process validation lifecycle and 
pharmaceutical quality system (PQS) assessment. Since publication of 
``Pharmaceutical Current Good Manufacturing Practices (CGMPs)

[[Page 41546]]

for the 21st Century--A Risk Based Approach'' in 2004,\1\ CDER has 
continued to promote its vision of a maximally efficient, agile, 
flexible manufacturing sector that reliably produces high-quality drug 
products without extensive regulatory oversight. The draft guidance for 
industry on ``Request for Quality Metrics'' and this technical 
reference document continues the outreach policy of FDA so as to ensure 
successful implementation of CDER's objectives outlined in the 21st 
Century publication. The objectives of CDER's metric program can best 
be achieved through collaboration and mutual recognition of standards 
for metric indicators and data exchange/reporting.
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm137175.htm (Fall 2004) (last visited: March 17, 2016).
---------------------------------------------------------------------------

    The purpose of this Guide is to provide technical recommendations 
for the submission of quality metric data. It is intended to ensure 
clear expectations for industry on the submission of quality metric 
data as described in the ``Request for Quality Metrics'' draft 
guidance. We note that the comment period for that draft guidance 
closed in November 2015 and that the comments that were received are 
undergoing evaluation. This Guide is intended to be a companion 
document to the July 28, 2015, draft guidance. There may be 
modifications to the draft guidance and this guide based on our 
evaluation of the submitted comments. Our goal is to institute 
efficient regulatory review, compliance oversight, and inspection 
policies established on risk-based methods, including quality metric 
reporting. This Guide is intended to facilitate collaboration between 
industry and FDA regarding the best methodologies to address all issues 
of implementation. Due to the inherent variability among reporting 
establishments' implementation of the process validation lifecycle and 
PQS assessment, it is difficult to identify and compare quality issues 
between firms. As such, FDA recognizes the importance of industry input 
and agreement regarding standardized indicators of manufacturing and 
product quality.
    This guide is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The current version of the guide 
will represent the current thinking of FDA on this topic. 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. Paperwork Reduction Act of 1995

    This guide refers to previously approved collections of information 
that are subject to review by the Office of Management and Budget under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Relevant to 
this collection of information, FDA published a document entitled 
``Request for Quality Metrics; Notice of Draft Guidance and Public 
Meeting; Request for Comments'' in the Federal Register of July 28, 
2015 (80 FR 44973). In Section IV, ``Paperwork Reduction Act of 1995,'' 
FDA estimated the burden that would cover the use of technical 
standards discussed in this draft guide.

III. Electronic Access

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

    Dated: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15099 Filed 6-24-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices                                              41545

                                                  DEPARTMENT OF HEALTH AND                                manner detailed (see ‘‘Written/Paper                      Docket: For access to the docket to
                                                  HUMAN SERVICES                                          Submissions’’ and ‘‘Instructions’’).                   read background documents or the
                                                                                                                                                                 electronic and written/paper comments
                                                  Food and Drug Administration                            Written/Paper Submissions
                                                                                                                                                                 received, go to http://
                                                                                                             Submit written/paper submissions as                 www.regulations.gov and insert the
                                                  [Docket No. FDA–2016–D–1594]
                                                                                                          follows:                                               docket number, found in brackets in the
                                                  Quality Metrics Technical                                  • Mail/Hand delivery/Courier (for                   heading of this document, into the
                                                  Conformance Guide—Technical                             written/paper submissions): Division of                ‘‘Search’’ box and follow the prompts
                                                  Specifications Document; Availability                   Dockets Management (HFA–305), Food                     and/or go to the Division of Dockets
                                                                                                          and Drug Administration, 5630 Fishers                  Management, 5630 Fishers Lane, Rm.
                                                  AGENCY:    Food and Drug Administration,                Lane, Rm. 1061, Rockville, MD 20852.                   1061, Rockville, MD 20852.
                                                  HHS.                                                       • For written/paper comments                           Submit written requests for single
                                                  ACTION:Notice of availability; request                  submitted to the Division of Dockets                   copies of the draft guide to the Division
                                                  for comment.                                            Management, FDA will post your                         of Drug Information, Center for Drug
                                                                                                          comment, as well as any attachments,                   Evaluation and Research (CDER), Food
                                                  SUMMARY:   The Food and Drug                            except for information submitted,
                                                  Administration (FDA or Agency) is                                                                              and Drug Administration, 10001 New
                                                                                                          marked and identified, as confidential,                Hampshire Ave., Hillandale Building,
                                                  announcing the availability of a                        if submitted as detailed in
                                                  Technical Specifications Document                                                                              4th Floor, Silver Spring, MD 20993–
                                                                                                          ‘‘Instructions.’’
                                                  entitled ‘‘Quality Metrics Technical                                                                           0002; or to the Office of
                                                                                                             Instructions: All submissions received
                                                  Conformance Guide, Version 1.0.’’ This                                                                         Communication, Outreach and
                                                                                                          must include the Docket No. FDA–
                                                  Guide provides technical                                2016–D–1594 for ‘‘Quality Metrics                      Development, Center for Biologics
                                                  recommendations for the submission of                   Technical Conformance Guide—                           Evaluation and Research (CBER), Food
                                                  quality metric data. It serves as the                   Technical Specifications Document.’’                   and Drug Administration, 10903 New
                                                  technical reference for implementation                  Received comments will be placed in                    Hampshire Ave., Bldg. 71, Rm. 3128,
                                                  of the draft FDA guidance for industry,                 the docket and, except for those                       Silver Spring, MD 20993–0002. Send
                                                  when finalized, on ‘‘Request for Quality                submitted as ‘‘Confidential                            one self-addressed adhesive label to
                                                  Metrics,’’ dated July 28, 2015.                         Submissions,’’ publicly viewable at                    assist that office in processing your
                                                                                                          http://www.regulations.gov or at the                   requests. See the SUPPLEMENTARY
                                                  DATES: Although you can comment on
                                                                                                          Division of Dockets Management                         INFORMATION section for electronic
                                                  any guidance at any time (see 21 CFR
                                                                                                          between 9 a.m. and 4 p.m., Monday                      access to the draft guidance document.
                                                  10.115(g)(5)), to ensure that the Agency
                                                                                                          through Friday.                                        All comments should be identified with
                                                  considers your comment on this draft
                                                                                                             • Confidential Submissions—To                       the docket number found in brackets in
                                                  guidance before it begins work on the
                                                                                                          submit a comment with confidential                     the heading of this document.
                                                  final version of the guidance, submit
                                                  either electronic or written comments                   information that you do not wish to be                 FOR FURTHER INFORMATION CONTACT: Tara
                                                  on the draft guidance by September 26,                  made publicly available, submit your                   Gooen Bizjak, Center for Drug
                                                  2016.                                                   comments only as a written/paper                       Evaluation and Research, Food and
                                                  ADDRESSES: You may submit comments                      submission. You should submit two                      Drug Administration, 10903 New
                                                  as follows:                                             copies total. One copy will include the                Hampshire Ave., Bldg. 51, Rm. 2109,
                                                                                                          information you claim to be confidential               Silver Spring, MD 20993–0002,
                                                  Electronic Submissions                                  with a heading or cover note that states               Tara.Gooen@fda.hhs.gov, 301–796–
                                                    Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                               3257; or Stephen Ripley, Center for
                                                  following way:                                          CONFIDENTIAL INFORMATION.’’ The                        Biologics Evaluation and Research,
                                                    • Federal eRulemaking Portal: http://                 Agency will review this copy, including                Food and Drug Administration, 10903
                                                  www.regulations.gov. Follow the                         the claimed confidential information, in               New Hampshire Ave., Bldg. 71, Rm.
                                                  instructions for submitting comments.                   its consideration of comments. The                     7301, Silver Spring, MD 20993–0002,
                                                  Comments submitted electronically,                      second copy, which will have the                       240–402–7911.
                                                  including attachments, to http://                       claimed confidential information                       SUPPLEMENTARY INFORMATION:
                                                  www.regulations.gov will be posted to                   redacted/blacked out, will be available
                                                                                                          for public viewing and posted on http://               I. Background
                                                  the docket unchanged. Because your
                                                  comment will be made public, you are                    www.regulations.gov. Submit both                          FDA is announcing the availability of
                                                  solely responsible for ensuring that your               copies to the Division of Dockets                      a Technical Specifications Document for
                                                  comment does not include any                            Management. If you do not wish your                    industry entitled ‘‘Quality Metrics
                                                  confidential information that you or a                  name and contact information to be                     Technical Conformance Guide, Version
                                                  third party may not wish to be posted,                  made publicly available, you can                       1.0.’’ This Guide supplements the draft
                                                  such as medical information, your or                    provide this information on the cover                  FDA guidance for industry on ‘‘Request
                                                  anyone else’s Social Security number, or                sheet and not in the body of your                      for Quality Metrics,’’ available at http://
                                                  confidential business information, such                 comments and you must identify this                    www.fda.gov/downloads/drugs/
                                                  as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                   guidancecompliance
                                                  that if you include your name, contact                  information marked as ‘‘confidential’’                 regulatoryinformation/guidances/
                                                  information, or other information that                  will not be disclosed except in                        ucm455957.pdf, and provides
                                                  identifies you in the body of your                      accordance with 21 CFR 10.20 and other                 recommendations about submission of
mstockstill on DSK3G9T082PROD with NOTICES




                                                  comments, that information will be                      applicable disclosure law. For more                    records and other information that will
                                                  posted on http://www.regulations.gov.                   information about FDA’s posting of                     support FDA’s calculation of quality
                                                    • If you want to submit a comment                     comments to public dockets, see 80 FR                  metrics as part of the process validation
                                                  with confidential information that you                  56469, September 18, 2015, or access                   lifecycle and pharmaceutical quality
                                                  do not wish to be made available to the                 the information at: http://www.fda.gov/                system (PQS) assessment. Since
                                                  public, submit the comment as a                         regulatoryinformation/dockets/                         publication of ‘‘Pharmaceutical Current
                                                  written/paper submission and in the                     default.htm.                                           Good Manufacturing Practices (CGMPs)


                                             VerDate Sep<11>2014   18:52 Jun 24, 2016   Jkt 238001   PO 00000   Frm 00038   Fmt 4703   Sfmt 4703   E:\FR\FM\27JNN1.SGM   27JNN1


                                                  41546                          Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices

                                                  for the 21st Century—A Risk Based                       of the applicable statutes and                         DATES:  Submit electronic or written
                                                  Approach’’ in 2004,1 CDER has                           regulations.                                           comments concerning this document at
                                                  continued to promote its vision of a                                                                           any time. These modifications to the list
                                                                                                          II. Paperwork Reduction Act of 1995
                                                  maximally efficient, agile, flexible                                                                           of recognized standards are effective
                                                  manufacturing sector that reliably                        This guide refers to previously                      June 27, 2016.
                                                  produces high-quality drug products                     approved collections of information that               ADDRESSES: You may submit comments
                                                  without extensive regulatory oversight.                 are subject to review by the Office of                 as follows:
                                                  The draft guidance for industry on                      Management and Budget under the
                                                  ‘‘Request for Quality Metrics’’ and this                Paperwork Reduction Act of 1995 (44                    Electronic Submissions
                                                  technical reference document continues                  U.S.C. 3501–3520). Relevant to this                      Submit electronic comments in the
                                                  the outreach policy of FDA so as to                     collection of information, FDA                         following way:
                                                  ensure successful implementation of                     published a document entitled ‘‘Request                  • Federal eRulemaking Portal: http://
                                                  CDER’s objectives outlined in the 21st                  for Quality Metrics; Notice of Draft                   www.regulations.gov. Follow the
                                                  Century publication. The objectives of                  Guidance and Public Meeting; Request                   instructions for submitting comments.
                                                  CDER’s metric program can best be                       for Comments’’ in the Federal Register                 Comments submitted electronically,
                                                  achieved through collaboration and                      of July 28, 2015 (80 FR 44973). In                     including attachments, to http://
                                                  mutual recognition of standards for                     Section IV, ‘‘Paperwork Reduction Act                  www.regulations.gov will be posted to
                                                  metric indicators and data exchange/                    of 1995,’’ FDA estimated the burden that               the docket unchanged. Because your
                                                  reporting.                                              would cover the use of technical                       comment will be made public, you are
                                                     The purpose of this Guide is to                      standards discussed in this draft guide.               solely responsible for ensuring that your
                                                  provide technical recommendations for                                                                          comment does not include any
                                                                                                          III. Electronic Access                                 confidential information that you or a
                                                  the submission of quality metric data. It
                                                  is intended to ensure clear expectations                  Persons with access to the Internet                  third party may not wish to be posted,
                                                  for industry on the submission of                       may obtain the draft guide at either                   such as medical information, your or
                                                  quality metric data as described in the                 http://www.fda.gov/Drugs/Guidance                      anyone else’s Social Security number, or
                                                  ‘‘Request for Quality Metrics’’ draft                   ComplianceRegulatoryInformation/                       confidential business information, such
                                                  guidance. We note that the comment                      Guidances/default.htm, http://                         as a manufacturing process. Please note
                                                  period for that draft guidance closed in                www.fda.gov/BiologicsBloodVaccines/                    that if you include your name, contact
                                                  November 2015 and that the comments                     GuidanceCompliance                                     information, or other information that
                                                  that were received are undergoing                       RegulatoryInformation/default.htm or                   identifies you in the body of your
                                                  evaluation. This Guide is intended to be                http://www.regulations.gov.                            comments, that information will be
                                                  a companion document to the July 28,                      Dated: June 21, 2016.                                posted on http://www.regulations.gov.
                                                  2015, draft guidance. There may be                                                                               • If you want to submit a comment
                                                                                                          Leslie Kux,
                                                  modifications to the draft guidance and                                                                        with confidential information that you
                                                                                                          Associate Commissioner for Policy.                     do not wish to be made available to the
                                                  this guide based on our evaluation of                   [FR Doc. 2016–15099 Filed 6–24–16; 8:45 am]
                                                  the submitted comments. Our goal is to                                                                         public, submit the comment as a
                                                  institute efficient regulatory review,
                                                                                                          BILLING CODE 4164–01–P                                 written/paper submission and in the
                                                  compliance oversight, and inspection                                                                           manner detailed (see ‘‘Written/Paper
                                                  policies established on risk-based                                                                             Submissions’’ and ‘‘Instructions’’).
                                                                                                          DEPARTMENT OF HEALTH AND
                                                  methods, including quality metric                       HUMAN SERVICES                                         Written/Paper Submissions
                                                  reporting. This Guide is intended to                                                                              Submit written/paper submissions as
                                                  facilitate collaboration between industry               Food and Drug Administration                           follows:
                                                  and FDA regarding the best                                                                                        • Mail/Hand delivery/Courier (for
                                                  methodologies to address all issues of                  [Docket No. FDA–2004–N–0451]
                                                                                                                                                                 written/paper submissions): Division of
                                                  implementation. Due to the inherent                                                                            Dockets Management (HFA–305), Food
                                                  variability among reporting                             Food and Drug Administration
                                                                                                          Modernization Act of 1997:                             and Drug Administration, 5630 Fishers
                                                  establishments’ implementation of the                                                                          Lane, rm. 1061, Rockville, MD 20852.
                                                  process validation lifecycle and PQS                    Modifications to the List of Recognized
                                                                                                          Standards, Recognition List Number:                       • For written/paper comments
                                                  assessment, it is difficult to identify and                                                                    submitted to the Division of Dockets
                                                  compare quality issues between firms.                   043
                                                                                                                                                                 Management, FDA will post your
                                                  As such, FDA recognizes the importance                  AGENCY:    Food and Drug Administration,               comment, as well as any attachments,
                                                  of industry input and agreement                         HHS.                                                   except for information submitted,
                                                  regarding standardized indicators of                                                                           marked and identified, as confidential,
                                                                                                          ACTION:   Notice.
                                                  manufacturing and product quality.                                                                             if submitted as detailed in
                                                     This guide is being issued consistent                SUMMARY:   The Food and Drug                           ‘‘Instructions.’’
                                                  with FDA’s good guidance practices                      Administration (FDA) is announcing a                      Instructions: All submissions received
                                                  regulation (21 CFR 10.115). The current                 publication containing modifications                   must include the Docket No. FDA–
                                                  version of the guide will represent the                 the Agency is making to the list of                    2004–N–0451 for ‘‘Food and Drug
                                                  current thinking of FDA on this topic.                  standards FDA recognizes for use in                    Administration Modernization Act of
                                                  It does not establish any rights for any                premarket reviews (FDA Recognized                      1997: Modifications to the List of
                                                  person and is not binding on FDA or the                 Consensus Standards). This publication,                Recognized Standards, Recognition List
mstockstill on DSK3G9T082PROD with NOTICES




                                                  public. You can use an alternative                      entitled ‘‘Modifications to the List of                Number: 043.’’ Received comments will
                                                  approach if it satisfies the requirements               Recognized Standards, Recognition List                 be placed in the docket and, except for
                                                                                                          Number: 043’’ (Recognition List                        those submitted as ‘‘Confidential
                                                     1 http://www.fda.gov/Drugs/Development
                                                                                                          Number: 043), will assist manufacturers                Submissions,’’ publicly viewable at
                                                  ApprovalProcess/Manufacturing/Questionsand
                                                  AnswersonCurrentGoodManufacturing
                                                                                                          who elect to declare conformity with                   http://www.regulations.gov or at the
                                                  PracticescGMPforDrugs/ucm137175.htm (Fall 2004)         consensus standards to meet certain                    Division of Dockets Management
                                                  (last visited: March 17, 2016).                         requirements for medical devices.                      between 9 a.m. and 4 p.m., Monday


                                             VerDate Sep<11>2014   18:52 Jun 24, 2016   Jkt 238001   PO 00000   Frm 00039   Fmt 4703   Sfmt 4703   E:\FR\FM\27JNN1.SGM   27JNN1



Document Created: 2016-06-25 02:06:31
Document Modified: 2016-06-25 02:06:31
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; request for comment.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 26, 2016.
ContactTara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, [email protected], 301-796-3257; or 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.
FR Citation81 FR 41545 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR