82 FR 40159 - Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability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 163 (August 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 163 (August 24, 2017)
| Page Range | 40159-40160 | |
| FR Document | 2017-17919 |
[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)] [Notices] [Pages 40159-40160] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17919] ----------------------------------------------------------------------- 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Drug Administration [Docket No. FDA-2017-D-1956] Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance).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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 23, 2017.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''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and [[Page 40160]] 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, [email protected]. 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 18, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17919 Filed 8-21-17; 11:15 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices 40159
Bureau (CB) is responsible for This announcement is a request for objective review committees. The web-
administering the review of eligible continued approval of the information based system permits reviewers to
grant applications submitted in collection system, the Reviewer access and update their information at
response to funding opportunity Recruitment Module (RRM). CB uses a will and as needed. The RRM is
announcements issued by CB. CB web-based data collection form and accessible by the general public via
ensures that the objective review database to gather critical reviewer https://rrm.grantsolutions.gov/
process is independent, efficient, information in drop down menu format AgencyPortal/cb.aspx.
effective, economical, and complies for data such as: Degree, occupation,
affiliations with organizations and Respondents: Generally, our
with the applicable statutes, regulations, reviewers are current or retired
and policies. Applications are reviewed institutions that serve special
populations, and demographic professionals with backgrounds in child
by subject experts knowledgeable in welfare and related fields and in some
information that may be voluntarily
child welfare and related fields. Review instances current or former foster care
provided by a potential reviewer.
findings are advisory to CB; CB is These data elements help CB find and parents or clients.
responsible for making award decisions. select expert grant reviewers for
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Reviewer Recruitment Module ......................................................................... 500 1 .25 125
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND on the draft guidance by October 23,
Hours: 125. HUMAN SERVICES 2017.
In compliance with the requirements ADDRESSES: You may submit comments
of the Paperwork Reduction Act of 1995 Food and Drug Administration
as follows:
(Pub. L. 104–13, 44 U.S.C. Chap 35), the [Docket No. FDA–2017–D–1956]
Administration for Children and Electronic Submissions
Families is soliciting public comment Identifying Trading Partners Under the Submit electronic comments in the
on the specific aspects of the Drug Supply Chain Security Act; Draft following way:
information collection described above. Guidance for Industry; Availability
Copies of the proposed collection of • Federal eRulemaking Portal:
information can be obtained and AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the
comments may be forwarded by writing HHS. instructions for submitting comments.
to the Administration for Children and ACTION: Notice of availability. Comments submitted electronically,
Families, Office of Planning, Research including attachments, to https://
and Evaluation, 330 C Street SW., SUMMARY: The Food and Drug www.regulations.gov will be posted to
Washington DC 20201. Attn: ACF Administration (FDA or Agency) is the docket unchanged. Because your
Reports Clearance Officer. Email announcing the availability of a draft comment will be made public, you are
address: infocollection@acf.hhs.gov. All guidance for industry entitled solely responsible for ensuring that your
requests should be identified by the title ‘‘Identifying Trading Partners Under the comment does not include any
of the information collection. Drug Supply Chain Security Act’’ (draft confidential information that you or a
trading partner guidance). FDA is third party may not wish to be posted,
The Department specifically requests
issuing this guidance to assist industry such as medical information, your or
comments on: (a) Whether the proposed
and State and local governments in anyone else’s Social Security number, or
collection of information is necessary
understanding how to categorize the confidential business information, such
for the proper performance of the
entities in the drug supply chain in as a manufacturing process. Please note
functions of the agency, including
accordance with the Drug Supply Chain that if you include your name, contact
whether the information shall have
Security Act (DSCSA). This guidance information, or other information that
practical utility; (b) the accuracy of the
explains how to determine when certain identifies you in the body of your
agency’s estimate of the burden of the
statutory requirements will apply to comments, that information will be
proposed collection of information; (c)
entities that may be considered trading posted on https://www.regulations.gov.
the quality, utility, and clarity of the
information to be collected; and (d) partners in the drug supply chain. FDA • If you want to submit a comment
ways to minimize the burden of the is also soliciting public input specific to with confidential information that you
collection of information on the activities of ‘‘private-label do not wish to be made available to the
respondents, including through the use distributors’’ of drug products and public, submit the comment as a
of automated collection techniques or whether those activities fall within the written/paper submission and in the
other forms of information technology. definitions under DSCSA of the various manner detailed (see ‘‘Written/Paper
Consideration will be given to trading partners. Submissions’’ and ‘‘Instructions’’).
rmajette on DSKBCKNHB2PROD with NOTICES
comments and suggestions submitted DATES: Although you can comment on Written/Paper Submissions
within 60 days of this publication. any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency Submit written/paper submissions as
Robert Sargis, considers your comment on this draft follows:
Reports Clearance Officer. guidance before it begins work on the • Mail/Hand delivery/Courier (for
[FR Doc. 2017–17935 Filed 8–23–17; 8:45 am] final version of the guidance, submit written/paper submissions): Dockets
BILLING CODE 4184–01–P either electronic or written comments Management Staff (HFA–305), Food and
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![40160 Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
Drug Administration, 5630 Fishers Submit written requests for single II. Additional Issues for Consideration:
Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to the Specific Request for Comments and
• For written/paper comments Division of Drug Information, Center for Information
submitted to the Dockets Management Drug Evaluation and Research, Food
Staff, FDA will post your comment, as In addition to comments on the draft
and Drug Administration, 10001 New guidance generally, FDA is requesting
well as any attachments, except for Hampshire Ave., Hillandale Building,
information submitted, marked and comments specifically related to the
4th Floor, Silver Spring, MD 20993– activities of private-label distributors
identified, as confidential, if submitted 0002; or to the Office of
as detailed in ‘‘Instructions.’’ (PLDs), and whether those activities fall
Instructions: All submissions received Communication, Outreach and within the definitions under DSCSA of
must include the Docket No. FDA– Development, Center for Biologics the various trading partners. FDA
2017–D–1956 for ‘‘Identifying Trading Evaluation and Research (CBER), Food considers a PLD to be an entity that
Partners Under the Drug Supply Chain and Drug Administration, 10903 New owns and distributes a manufactured
Security Act; Draft Guidance for Hampshire Ave., Bldg. 71, Rm. 3128, product under its own label or trade
Industry; Availability.’’ Received Silver Spring, MD 20993–0002. Send name. Because there are many different
comments will be placed in the docket one self-addressed adhesive label to business models for PLDs, resulting in
and, except for those submitted as assist that office in processing your situations where a PLD could be
‘‘Confidential Submissions,’’ publicly requests. See the SUPPLEMENTARY considered a manufacturer, wholesale
viewable at https://www.regulations.gov INFORMATION section for electronic distributor, or dispenser, we are asking
or at the Dockets Management Staff access to the draft guidance document. for comments on how the different
between 9 a.m. and 4 p.m., Monday business models might impact a PLD’s
FOR FURTHER INFORMATION CONTACT: status as an authorized trading partner
through Friday.
• Confidential Submissions—To Melissa Mannion, Office of Compliance, under the DSCSA.
submit a comment with confidential Center for Drug Evaluation and This draft guidance is being issued
information that you do not wish to be Research, Food and Drug consistent with FDA’s good guidance
made publicly available, submit your Administration, 10903 New Hampshire practices (see 21 CFR 10.115). The draft
comments only as a written/paper Ave., Silver Spring, MD 20993–0002, guidance, when finalized, will represent
submission. You should submit two 301–796–3130, drugtrackandtrace@ the current thinking of FDA on
copies total. One copy will include the fda.hhs.gov. ‘‘Identifying Trading Partners under the
information you claim to be confidential Drug Supply Chain Security Act.’’ It
with a heading or cover note that states SUPPLEMENTARY INFORMATION: does not establish any rights for any
‘‘THIS DOCUMENT CONTAINS I. Background person and is not binding on FDA or the
CONFIDENTIAL INFORMATION.’’ The public. You can use an alternative
Agency will review this copy, including FDA is announcing the availability of approach if it satisfies the requirements
the claimed confidential information, in a draft guidance for industry entitled of the applicable statutes and
its consideration of comments. The ‘‘Identifying Trading Partners Under the regulations.
second copy, which will have the Drug Supply Chain Security Act.’’ The
claimed confidential information III. Electronic Access
DSCSA (Title II of Pub. L. 113–54)
redacted/blacked out, will be available establishes new requirements to develop Persons with access to the internet
for public viewing and posted on and enhance drug distribution security may obtain the draft guidance at either
https://www.regulations.gov. Submit by 2023. It does this, in part, by defining http://www.fda.gov/Drugs/Guidance
both copies to the Dockets Management ComplianceRegulatoryInformation/
different types of entities in the drug
Staff. If you do not wish your name and Guidances/default.htm, http://
supply chain as trading partners (i.e.,
contact information to be made publicly www.fda.gov/BiologicsBloodVaccines/
available, you can provide this manufacturers, repackagers, wholesale
GuidanceComplianceRegulatory
information on the cover sheet and not distributors, third-party logistics
Information/Guidances/default.htm, or
in the body of your comments and you providers, and dispensers). Among https://www.regulations.gov.
must identify this information as other things, the DSCSA requires that
trading partners of manufacturers, Dated: August 18, 2017.
‘‘confidential.’’ Any information marked
wholesale distributors, dispensers, and Leslie Kux,
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20 repackagers must meet the applicable Associate Commissioner for Policy.
and other applicable disclosure law. For requirements for being ‘‘authorized [FR Doc. 2017–17919 Filed 8–21–17; 11:15 am]
more information about FDA’s posting trading partners.’’ In addition, the BILLING CODE 4164–01–P
of comments to public dockets, see 80 DSCSA outlines requirements for
FR 56469, September 18, 2015, or access specific trading partners, including drug
the information at: https://www.gpo.gov/ product tracing and licensure DEPARTMENT OF HEALTH AND
fdsys/pkg/FR-2015-09-18/pdf/2015- HUMAN SERVICES
requirements. FDA has received
23389.pdf. questions about which types of entities
Docket: For access to the docket to Health Resources and Services
are included in each of the trading Administration
read background documents or the partner definitions and this guidance is
electronic and written/paper comments intended to help clarify and explain the Notice of Supplemental Awards to the
received, go to https://
rmajette on DSKBCKNHB2PROD with NOTICES
relevant statutory provisions. The Territorial Health Departments of
www.regulations.gov and insert the Puerto Rico, American Samoa, and
guidance covers who is considered to be
docket number, found in brackets in the U.S. Virgin Islands for the Zika
a manufacturer, a repackager, a
heading of this document, into the Maternal and Child Health Services
‘‘Search’’ box and follow the prompts wholesale drug distributor, a third-party
logistics provider, and a dispenser for Program
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, purposes of certain DSCSA AGENCY:Health Resources and Services
Rockville, MD 20852. requirements. Administration (HRSA), HHS.
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Document Created: 2018-10-24 12:36:03
Document Modified: 2018-10-24 12:36:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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 23, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 40159 |
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