82 FR 39589 - Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability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)
Food and Drug Administration
Federal Register Volume 82, Issue 160 (August 21, 2017)
| Page Range | 39589-39590 | |
| FR Document | 2017-17569 |
[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Drug Administration [Docket No. FDA-2017-D-1956] Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance).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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 20, 2017.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
VerDate Sep<11>2014 18:37 Aug 18, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\21AUN1.SGM 21AUN1](https://thefederalregister.org/doc/82_FR_39749/page/2.svg)
Document Created: 2017-08-19 00:44:45
Document Modified: 2017-08-19 00:44:45
| 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 20, 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 39589 |
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