82_FR_39749 82 FR 39589 - Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

82 FR 39589 - Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 160 (August 21, 2017)

Page Range39589-39590
FR Document2017-17569

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ``private-label distributors'' of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.

Federal Register, Volume 82 Issue 160 (Monday, August 21, 2017)
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39589-39590]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17569]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1956]


Identifying Trading Partners Under the Drug Supply Chain Security 
Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Identifying Trading Partners Under the Drug Supply Chain Security 
Act'' (draft trading partner guidance). FDA is issuing this guidance to 
assist industry and State and local governments in understanding how to 
categorize the entities in the drug supply chain in accordance with the 
Drug Supply Chain Security Act (DSCSA). This guidance explains how to 
determine when certain statutory requirements will apply to entities 
that may be considered trading partners in the drug supply chain. FDA 
is also soliciting public input specific to the activities of 
``private-label distributors'' of drug products and whether those 
activities fall within the definitions under DSCSA of the various 
trading partners.

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 October 20, 2017.

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'').

[[Page 39590]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-1956 for ``Identifying Trading Partners Under the Drug 
Supply Chain Security Act; Draft Guidance for Industry; Availability.'' 
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 Dockets Management Staff 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 Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft 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; 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.

FOR FURTHER INFORMATION CONTACT: Melissa Mannion, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
drugtrackandtrace@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Identifying Trading Partners Under the Drug Supply Chain 
Security Act.'' The DSCSA (Title II of Pub. L. 113-54) establishes new 
requirements to develop and enhance drug distribution security by 2023. 
It does this, in part, by defining different types of entities in the 
drug supply chain as trading partners (i.e., manufacturers, 
repackagers, wholesale distributors, third-party logistics providers, 
and dispensers). Among other things, the DSCSA requires that trading 
partners of manufacturers, wholesale distributors, dispensers, and 
repackagers must meet the applicable requirements for being 
``authorized trading partners.'' In addition, the DSCSA outlines 
requirements for specific trading partners, including drug product 
tracing and licensure requirements. FDA has received questions about 
which types of entities are included in each of the trading partner 
definitions and this guidance is intended to help clarify and explain 
the relevant statutory provisions. The guidance covers who is 
considered to be a manufacturer, a repackager, a wholesale drug 
distributor, a third-party logistics provider, and a dispenser for 
purposes of certain DSCSA requirements.

II. Additional Issues for Consideration: Specific Request for Comments 
and Information

    In addition to comments on the draft guidance generally, FDA is 
requesting comments specifically related to the activities of private-
label distributors (PLDs), and whether those activities fall within the 
definitions under DSCSA of the various trading partners. FDA considers 
a PLD to be an entity that owns and distributes a manufactured product 
under its own label or trade name. Because there are many different 
business models for PLDs, resulting in situations where a PLD could be 
considered a manufacturer, wholesale distributor, or dispenser, we are 
asking for comments on how the different business models might impact a 
PLD's status as an authorized trading partner under the DSCSA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (see 21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Identifying 
Trading Partners under the Drug Supply Chain Security Act.'' 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.

III. Electronic Access

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

    Dated: August 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17569 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices                                              39589

                                                      Submit petitions electronically to                    default.htm. The eStudy Data guidance                 ACTION:   Notice of availability.
                                                    https://www.regulations.gov at Docket                   implements the electronic submission
                                                    No. FDA–2013–S–0610. Submit written                     requirements of section 745A(a) of the                SUMMARY:    The Food and Drug
                                                    petitions (two copies are required) to the              Food, Drug and Cosmetic Act (21 U.S.C.                Administration (FDA or Agency) is
                                                    Dockets Management Staff (HFA–305),                     379k–1(a)) for study data contained in                announcing the availability of a draft
                                                    Food and Drug Administration, 5630                      new drug applications (NDAs),                         guidance for industry entitled
                                                    Fishers Lane, Rm. 1061, Rockville, MD                   abbreviated new drug applications                     ‘‘Identifying Trading Partners Under the
                                                    20852.                                                  (ANDAs), biologics license applications               Drug Supply Chain Security Act’’ (draft
                                                                                                            (BLAs), and investigational new drug                  trading partner guidance). FDA is
                                                      Dated: August 15, 2015.
                                                                                                            applications (INDs) to FDA’s Center for               issuing this guidance to assist industry
                                                    Leslie Kux,                                                                                                   and State and local governments in
                                                                                                            Biologics Evaluation and Research or
                                                    Associate Commissioner for Policy.                      CDER by specifying the format for                     understanding how to categorize the
                                                    [FR Doc. 2017–17566 Filed 8–18–17; 8:45 am]             electronic submissions. The initial                   entities in the drug supply chain in
                                                    BILLING CODE 4164–01–P                                  timetable for implementing electronic                 accordance with the Drug Supply Chain
                                                                                                            submission requirements for study data                Security Act (DSCSA). This guidance
                                                                                                            was December 17, 2016 (24 months after                explains how to determine when certain
                                                    DEPARTMENT OF HEALTH AND                                issuance of final guidance for NDAs,                  statutory requirements will apply to
                                                    HUMAN SERVICES                                          BLAs, ANDAs, and 36 months for INDs).                 entities that may be considered trading
                                                                                                            The eStudy Data guidance states that a                partners in the drug supply chain. FDA
                                                    Food and Drug Administration                                                                                  is also soliciting public input specific to
                                                                                                            Federal Register notice will specify the
                                                    [Docket No. FDA–2017–N–2363]                            transition date for all version updates               the activities of ‘‘private-label
                                                                                                            (with the month and day for the                       distributors’’ of drug products and
                                                    Electronic Study Data Submission;                       transition date corresponding to March                whether those activities fall within the
                                                    Data Standards; Support for Standard                    15).                                                  definitions under DSCSA of the various
                                                    for Exchange of Nonclinical Data                           The transition date for support of                 trading partners.
                                                    Implementation Guide Version 3.1                        version 3.1 of CDISC SEND IG is March                 DATES: Although you can comment on
                                                                                                            15, 2018. Although SEND IG version 3.1                any guidance at any time (see 21 CFR
                                                    AGENCY:    Food and Drug Administration,
                                                                                                            is supported as of this Federal Register              10.115(g)(5)), to ensure that the Agency
                                                    HHS.
                                                                                                            notice and sponsors or applicants are                 considers your comment on this draft
                                                    ACTION:   Notice.                                       encouraged to begin using it, the new                 guidance before it begins work on the
                                                    SUMMARY:   The Food and Drug                            version will only be required in                      final version of the guidance, submit
                                                    Administration’s (FDA or Agency)                        submissions for studies that start after              either electronic or written comments
                                                    Center for Drug Evaluation and Research                 March 15, 2019. The Catalog will list                 on the draft guidance by October 20,
                                                    (CDER) is announcing support for the                    March 15, 2019, as the ‘‘date                         2017.
                                                    3.1 version of Clinical Data Interchange                requirement begins.’’ When multiple
                                                                                                            versions of an FDA-supported standard                 ADDRESSES:    You may submit comments
                                                    Standards Consortium (CDISC) Standard                                                                         as follows:
                                                    for Exchange of Nonclinical Data (SEND                  are listed in the Catalog, sponsors or
                                                    IG 3.1), the end of support for the 3.0                 applicants can select a version to use.               Electronic Submissions
                                                                                                               The transition date for the end of FDA
                                                    version of SEND IG, and an update to                                                                            Submit electronic comments in the
                                                                                                            support for SEND IG 3.0 is March 15,
                                                    the FDA Data Standards Catalog                                                                                following way:
                                                                                                            2018. Therefore, FDA support for SEND
                                                    (Catalog). (See http://www.fda.gov/
                                                                                                            IG 3.0 will end for studies that start after            • Federal eRulemaking Portal:
                                                    forindustry/datastandards/                                                                                    https://www.regulations.gov. Follow the
                                                                                                            March 15, 2019. The Catalog will be
                                                    studydatastandards/default.htm.) SEND                                                                         instructions for submitting comments.
                                                                                                            updated to list March 15, 2019, as the
                                                    IG 3.1 has been available from CDISC                                                                          Comments submitted electronically,
                                                                                                            ‘‘date support ends.’’
                                                    (www.cdisc.org) since July 2016. FDA is                                                                       including attachments, to https://
                                                    encouraging sponsors and applicants to                  II. Electronic Access                                 www.regulations.gov will be posted to
                                                    use SEND IG 3.1 in investigational study                   Persons with access to the Internet                the docket unchanged. Because your
                                                    data provided in regulatory submissions                 may obtain the referenced material at                 comment will be made public, you are
                                                    to CDER.                                                https://www.fda.gov/ectd.                             solely responsible for ensuring that your
                                                    FOR FURTHER INFORMATION CONTACT: Ron                      Dated: August 15, 2017.                             comment does not include any
                                                    Fitzmartin, Center for Drug Evaluation                                                                        confidential information that you or a
                                                                                                            Leslie Kux,
                                                    and Research, Food and Drug                                                                                   third party may not wish to be posted,
                                                                                                            Associate Commissioner for Policy.
                                                    Administration, 10903 New Hampshire                                                                           such as medical information, your or
                                                                                                            [FR Doc. 2017–17567 Filed 8–18–17; 8:45 am]
                                                    Ave., Bldg. 51, Rm. 1115, Silver Spring,                                                                      anyone else’s Social Security number, or
                                                    MD 20993–0002, 301–796–5333, email:                     BILLING CODE 4164–01–P
                                                                                                                                                                  confidential business information, such
                                                    CDERDataStandards@fda.hhs.gov.                                                                                as a manufacturing process. Please note
                                                    SUPPLEMENTARY INFORMATION:                                                                                    that if you include your name, contact
                                                                                                            DEPARTMENT OF HEALTH AND
                                                                                                                                                                  information, or other information that
                                                    I. Background                                           HUMAN SERVICES
                                                                                                                                                                  identifies you in the body of your
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                      On December 17, 2014, FDA                             Food and Drug Administration                          comments, that information will be
                                                    published final guidance for industry                                                                         posted on https://www.regulations.gov.
                                                    entitled ‘‘Providing Regulatory                         [Docket No. FDA–2017–D–1956]                            • If you want to submit a comment
                                                    Submissions in Electronic Format—                                                                             with confidential information that you
                                                                                                            Identifying Trading Partners Under the
                                                    Standardized Study Data’’ (eStudy                                                                             do not wish to be made available to the
                                                                                                            Drug Supply Chain Security Act; Draft
                                                    Data), posted on FDA’s Study Data                                                                             public, submit the comment as a
                                                                                                            Guidance for Industry; Availability
                                                    Standards Resources Web page at                                                                               written/paper submission and in the
                                                    https://www.fda.gov/forindustry/                        AGENCY:    Food and Drug Administration,              manner detailed (see ‘‘Written/Paper
                                                    datastandards/studydatastandards/                       HHS.                                                  Submissions’’ and ‘‘Instructions’’).


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                                                    39590                        Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices

                                                    Written/Paper Submissions                               www.regulations.gov and insert the                    logistics provider, and a dispenser for
                                                       Submit written/paper submissions as                  docket number, found in brackets in the               purposes of certain DSCSA
                                                    follows:                                                heading of this document, into the                    requirements.
                                                       • Mail/Hand delivery/Courier (for                    ‘‘Search’’ box and follow the prompts
                                                                                                            and/or go to the Dockets Management                   II. Additional Issues for Consideration:
                                                    written/paper submissions): Dockets                                                                           Specific Request for Comments and
                                                    Management Staff (HFA–305), Food and                    Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                            Rockville, MD 20852.                                  Information
                                                    Drug Administration, 5630 Fishers
                                                    Lane, Rm. 1061, Rockville, MD 20852.                       Submit written requests for single
                                                                                                                                                                     In addition to comments on the draft
                                                       • For written/paper comments                         copies of the draft guidance to the
                                                                                                            Division of Drug Information, Center for              guidance generally, FDA is requesting
                                                    submitted to the Dockets Management                                                                           comments specifically related to the
                                                    Staff, FDA will post your comment, as                   Drug Evaluation and Research, Food
                                                                                                            and Drug Administration, 10001 New                    activities of private-label distributors
                                                    well as any attachments, except for                                                                           (PLDs), and whether those activities fall
                                                    information submitted, marked and                       Hampshire Ave., Hillandale Building,
                                                                                                            4th Floor, Silver Spring, MD 20993–                   within the definitions under DSCSA of
                                                    identified, as confidential, if submitted                                                                     the various trading partners. FDA
                                                    as detailed in ‘‘Instructions.’’                        0002; or to the Office of
                                                                                                            Communication, Outreach and                           considers a PLD to be an entity that
                                                       Instructions: All submissions received
                                                                                                            Development, Center for Biologics                     owns and distributes a manufactured
                                                    must include the Docket No. FDA–
                                                    2017–D–1956 for ‘‘Identifying Trading                   Evaluation and Research (CBER), Food                  product under its own label or trade
                                                    Partners Under the Drug Supply Chain                    and Drug Administration, 10903 New                    name. Because there are many different
                                                    Security Act; Draft Guidance for                        Hampshire Ave., Bldg. 71, Rm. 3128,                   business models for PLDs, resulting in
                                                    Industry; Availability.’’ Received                      Silver Spring, MD 20993–0002. Send                    situations where a PLD could be
                                                    comments will be placed in the docket                   one self-addressed adhesive label to                  considered a manufacturer, wholesale
                                                    and, except for those submitted as                      assist that office in processing your                 distributor, or dispenser, we are asking
                                                    ‘‘Confidential Submissions,’’ publicly                  requests. See the SUPPLEMENTARY                       for comments on how the different
                                                    viewable at https://www.regulations.gov                 INFORMATION section for electronic                    business models might impact a PLD’s
                                                    or at the Dockets Management Staff                      access to the draft guidance document.                status as an authorized trading partner
                                                    between 9 a.m. and 4 p.m., Monday                       FOR FURTHER INFORMATION CONTACT:                      under the DSCSA.
                                                    through Friday.                                         Melissa Mannion, Office of Compliance,
                                                                                                                                                                     This draft guidance is being issued
                                                       • Confidential Submissions—To                        Center for Drug Evaluation and
                                                                                                                                                                  consistent with FDA’s good guidance
                                                    submit a comment with confidential                      Research, Food and Drug
                                                                                                                                                                  practices (see 21 CFR 10.115). The draft
                                                    information that you do not wish to be                  Administration, 10903 New Hampshire
                                                                                                            Ave., Silver Spring, MD 20993–0002,                   guidance, when finalized, will represent
                                                    made publicly available, submit your                                                                          the current thinking of FDA on
                                                    comments only as a written/paper                        301–796–3130, drugtrackandtrace@
                                                                                                            fda.hhs.gov.                                          ‘‘Identifying Trading Partners under the
                                                    submission. You should submit two
                                                                                                                                                                  Drug Supply Chain Security Act.’’ It
                                                    copies total. One copy will include the                 SUPPLEMENTARY INFORMATION:
                                                                                                                                                                  does not establish any rights for any
                                                    information you claim to be confidential
                                                    with a heading or cover note that states                I. Background                                         person and is not binding on FDA or the
                                                    ‘‘THIS DOCUMENT CONTAINS                                   FDA is announcing the availability of              public. You can use an alternative
                                                    CONFIDENTIAL INFORMATION.’’ The                         a draft guidance for industry entitled                approach if it satisfies the requirements
                                                    Agency will review this copy, including                 ‘‘Identifying Trading Partners Under the              of the applicable statutes and
                                                    the claimed confidential information, in                Drug Supply Chain Security Act.’’ The                 regulations.
                                                    its consideration of comments. The                      DSCSA (Title II of Pub. L. 113–54)                    III. Electronic Access
                                                    second copy, which will have the                        establishes new requirements to develop
                                                    claimed confidential information                        and enhance drug distribution security                  Persons with access to the internet
                                                    redacted/blacked out, will be available                 by 2023. It does this, in part, by defining           may obtain the draft guidance at either
                                                    for public viewing and posted on                        different types of entities in the drug               http://www.fda.gov/Drugs/Guidance
                                                    https://www.regulations.gov. Submit                     supply chain as trading partners (i.e.,               ComplianceRegulatoryInformation/
                                                    both copies to the Dockets Management                   manufacturers, repackagers, wholesale                 Guidances/default.htm, http://www.fda.
                                                    Staff. If you do not wish your name and                 distributors, third-party logistics                   gov/BiologicsBloodVaccines/Guidance
                                                    contact information to be made publicly                 providers, and dispensers). Among                     ComplianceRegulatoryInformation/
                                                    available, you can provide this                         other things, the DSCSA requires that                 Guidances/default.htm, or https://
                                                    information on the cover sheet and not                  trading partners of manufacturers,                    www.regulations.gov.
                                                    in the body of your comments and you                    wholesale distributors, dispensers, and
                                                    must identify this information as                       repackagers must meet the applicable                    Dated: August 15, 2015.
                                                    ‘‘confidential.’’ Any information marked                requirements for being ‘‘authorized                   Leslie Kux,
                                                    as ‘‘confidential’’ will not be disclosed               trading partners.’’ In addition, the                  Associate Commissioner for Policy.
                                                    except in accordance with 21 CFR 10.20                  DSCSA outlines requirements for                       [FR Doc. 2017–17569 Filed 8–18–17; 8:45 am]
                                                    and other applicable disclosure law. For                specific trading partners, including drug             BILLING CODE 4164–01–P
                                                    more information about FDA’s posting                    product tracing and licensure
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    of comments to public dockets, see 80                   requirements. FDA has received
                                                    FR 56469, September 18, 2015, or access                 questions about which types of entities
                                                    the information at: https://www.gpo.gov/                are included in each of the trading
                                                    fdsys/pkg/FR-2015-09-18/pdf/2015-                       partner definitions and this guidance is
                                                    23389.pdf.                                              intended to help clarify and explain the
                                                       Docket: For access to the docket to                  relevant statutory provisions. The
                                                    read background documents or the                        guidance covers who is considered to be
                                                    electronic and written/paper comments                   a manufacturer, a repackager, a
                                                    received, go to https://                                wholesale drug distributor, a third-party


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Document Created: 2017-08-19 00:44:45
Document Modified: 2017-08-19 00:44:45
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.
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 October 20, 2017.
ContactMelissa Mannion, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected]
FR Citation82 FR 39589 

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