82 FR 3004 - Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 6 (January 10, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.'' This draft addresses questions about and clarifies FDA's expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA).

[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3004-3005]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4646]


Annual Reporting by Prescription Drug Wholesale Distributors and 
Third-Party Logistics Providers: Questions and Answers; Draft Guidance 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the availability of a draft guidance for industry entitled ``Annual 
Reporting by Prescription Drug Wholesale Distributors and Third-Party 
Logistics Providers: Questions and Answers.'' This draft addresses 
questions about and clarifies FDA's expectations for annual reporting 
to FDA by prescription drug wholesale distributors (wholesale 
distributors) and third-party logistics providers (3PLs) as required 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as 
amended by the Drug Supply Chain Security Act (DSCSA).

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 13, 2017.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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4646 for ``Annual Reporting by Prescription Drug Wholesale 
Distributors and Third-Party Logistics Providers: Questions and 
Answers; 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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to 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 Division of Dockets Management, 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: 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

    Section 204 of the DSCSA (Title II of Pub. L. 113-54) amended 
section 503(e)

[[Page 3005]]

of the FD&C Act (21 U.S.C. 353(e)) to require, under section 
503(e)(2)(A) of the FD&C Act (as amended), annual reporting by 
wholesale distributors, beginning on January 1, 2015. Section 
503(e)(2)(B) of the FD&C Act (as amended) requires FDA to make certain 
information about wholesale distributors' licensure available to the 
public on FDA's Web site. Section 205 of the DSCSA added section 584 to 
the FD&C Act (21 U.S.C. 360eee-3); under section 584 of the FD&C Act 
(as amended), 3PL facilities are required to report annually, beginning 
on November 27, 2014.
    FDA previously published the draft guidance ``DSCSA Implementation: 
Annual Reporting by Prescription Drug Wholesale Distributors and Third-
Party Logistics Providers'' (Annual Reporting draft guidance), which 
described who must report, what should be reported, when to report, and 
how to report (December 9, 2014, 79 FR 73083). The Annual Reporting 
draft guidance is available on the Wholesale Distributor and Third-
Party logistics Providers Reporting Web page at http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm423749.htm. This draft guidance 
supplements the information in the Annual Reporting draft guidance by 
addressing questions and comments that FDA received about annual 
reporting since publication of the Annual Reporting draft guidance. 
Topics covered in this guidance include clarifications about who must 
report, what should be reported, when to report, and how to report. 
This guidance also addresses questions related to the public 
availability of reported information.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). FDA intends to finalize 
this draft guidance and the Annual Reporting draft guidance in one 
unified final guidance on annual reporting requirements under the 
DSCSA. Once issued that unified final guidance will represent the 
current thinking of FDA regarding annual reporting by prescription drug 
wholesale distributors and third-party logistics providers. It will not 
establish any rights for any person and will not be binding on FDA or 
the public. You will be able to use an alternative approach to that 
described in the final guidance if it satisfies the requirements of the 
applicable statutes and regulations.

II. 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.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) 
(PRA), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party.
    This draft guidance addresses proposed information collections that 
are subject to review by OMB under the PRA. These information 
collections were also addressed in the draft guidance entitled ``Drug 
Supply Chain Security Act Implementation: Annual Reporting by 
Prescription Drug Wholesale Distributors and Third-Party Logistics 
Providers,'' the availability of which was announced in a notice 
published in the Federal Register of December 9, 2014. In that Federal 
Register notice, FDA published a 60-day notice requesting public 
comment on the proposed collections of information (79 FR 73083). This 
draft guidance provides further clarification regarding those 
information collections.
    In compliance with the PRA, FDA intends to submit these proposed 
collections of information to OMB for review and approval, including 
providing notice of that submission and opportunity for the public to 
comment to OMB on the proposed information collections. In accordance 
with the PRA, the agency will inform the public of OMB approval, 
including the associated currently valid OMB control number, before 
conducting or sponsoring a collection of information.

    Dated: January 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00233 Filed 1-9-17; 8:45 am]
 BILLING CODE 4164-01-P