[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40258-40260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1981]


Drug Supply Chain Security Act Standards for the Interoperable 
Exchange of Information for Tracing of Certain Human, Finished, 
Prescription Drugs; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``DSCSA 
Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs.'' This guidance identifies 
the standards necessary to facilitate adoption of secure, 
interoperable, electronic data exchange among the pharmaceutical 
distribution supply chain, and clarifies the trading partners, 
products, and transactions subject to such standards. This guidance is 
a revision of the draft guidance for industry entitled ``DSCSA 
Standards for the Interoperable Exchange of Information for Tracing of 
Certain Human, Finished, Prescription Drugs: How to Exchange Product 
Tracing Information,'' issued in November 2014 as required by the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by September 6, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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

[[Page 40259]]

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 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-2014-D-1981 for ``DSCSA Standards for the Interoperable Exchange of 
Information for Tracing of Certain Human, Finished, Prescription 
Drugs.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this 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, 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: Lysette Deshields, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
[email protected]; 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 revised draft guidance for 
industry entitled ``DSCSA Standards for the Interoperable Exchange of 
Information for Tracing of Certain Human, Finished, Prescription 
Drugs.'' The Drug Supply Chain Security Act (DSCSA) outlines 
requirements for enhanced drug distribution security, which include the 
steps to achieve interoperable, electronic tracing of products at the 
package level. These requirements for enhanced drug distribution 
security go into effect on November 27, 2023. Section 582(g)(1) of the 
FD&C Act (21 U.S.C. 360eee-1(g)(1)) sets forth enhanced drug 
distribution security requirements for trading partners, including 
adherence to standards established by FDA for the exchange of 
transaction information and transaction statements in a secure, 
interoperable, electronic manner and the verification of product at the 
package level. Additionally, section 582(h)(4)(A) of the FD&C Act 
specifies that FDA issue a draft guidance, and revise the draft 
guidance as appropriate, to identify and make recommendations with 
respect to the standards necessary for adoption in order to support the 
secure, interoperable, electronic data exchange among the 
pharmaceutical distribution supply chain that comply with a form and 
format developed by a widely recognized international standards 
development organization.
    In this revised draft guidance, FDA considered the standards 
established pursuant to sections 505D of the FD&C Act (21 U.S.C. 355e) 
and 582(a)(2) of the FD&C Act in the November 2014 draft guidance 
entitled ``DSCSA Standards for the Interoperable Exchange of 
Information for Tracing of Certain Human, Finished, Prescription Drugs: 
How to Exchange Product Tracing Information'' (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs). The pilot projects conducted per section 
582(j) of the FD&C Act also informed revisions made to this draft 
guidance.
    This revised draft guidance updates the policy articulated in the 
November 2014 draft guidance to reflect the enhanced drug distribution 
security requirements that will go into effect on November 27, 2023, 
including that paper-based methods of product tracing will no longer be 
permitted and verification of product at the package level will be 
required, unless a waiver, exception, or exemption applies. This 
revised draft guidance is intended to facilitate the creation of a 
uniform methodology for product tracing while ensuring the protection 
of confidential commercial information and trade secrets. FDA also 
published other guidances describing recommendations for enhanced drug 
distribution security, including the attributes necessary for enhanced 
product tracing and verification, which should be read in conjunction 
with this draft guidance (see FDA's Drug Supply Chain Security Law and 
Policies web page at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will

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represent the current thinking of FDA on ``DSCSA Standards for the 
Interoperable Exchange of Information for Tracing of Certain Human, 
Finished, Prescription Drugs.'' 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 draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). FDA 
intends to solicit public comment and obtain OMB approval for any 
information collections recommended in this guidance that are new or 
that would represent substantive or material modifications to those 
previously approved collections of information found in FDA regulations 
or guidance.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14342 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P