[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9004-9006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0688]


Standardization of Data and Documentation Practices for Product 
Tracing; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Standardization of Data and Documentation Practices for Product 
Tracing.'' The draft guidance elaborates on the standards for the 
interoperable exchange of transaction information, transaction history, 
and transaction statements (product tracing information)

[[Page 9005]]

provided under the drug supply chain security provisions of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to 
assist trading partners in standardizing the data contained in the 
product tracing information that trading partners must provide, 
capture, and maintain under the FD&C Act. In addition, this guidance 
includes recommendations for documentation practices that a trading 
partner can use to meet its product tracing obligations, including in 
situations where a trading partner is permitted by law to provide other 
trading partners with product tracing information that omits certain 
elements that would otherwise be required.

DATES: Submit either electronic or written comments on the draft 
guidance by May 1, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-2018-D-0688 for ``Standardization of Data and Documentation 
Practices for Product Tracing; 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.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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. 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: Connie Jung, 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

    On November 27, 2013, the Drug Supply Chain Security Act (Title II 
of Pub. L. 113-54) was signed into law. Section 202 of the Drug Supply 
Chain Security Act (DSCSA), which added new sections 581 and 582 to the 
FD&C Act (21 U.S.C. 360eee and 360eee-1), set forth new definitions and 
requirements related to product tracing. The DSCSA outlines critical 
steps to build an electronic, interoperable system by November 27, 
2023, that will identify and trace certain prescription drugs as they 
are distributed within the United States.
    Under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C 
Act, certain trading partners in the pharmaceutical distribution supply 
chain (manufacturers, wholesale distributors, dispensers, and 
repackagers) are required to capture, maintain, and provide the 
subsequent purchaser of certain prescription drug products with product 
tracing information. These requirements took effect on January 1, 2015, 
for manufacturers, wholesale distributors, and repackagers, and on July 
1, 2015, for dispensers.
    As required by section 582(a)(2)(A) of the FD&C Act, FDA 
established initial standards in 2014 to facilitate the interoperable 
exchange of transaction information, transaction history, and 
transaction statements between trading partners (79 FR 70878, November 
28, 2014). Those standards help trading partners comply with the 
requirements of section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the 
FD&C Act to provide the subsequent trading partners with product 
tracing information, in paper or electronic format, through the 
extension and/or use of current systems and processes.

[[Page 9006]]

    This draft guidance elaborates on the initial standards that FDA 
established in 2014. It is intended to assist trading partners in 
standardizing the data that are contained in the product tracing 
information they must provide to subsequent purchasers. It is also 
intended to help trading partners understand the data elements that 
should be included in the product tracing information, particularly in 
situations where they are permitted by law to provide other trading 
partners with product tracing information that omits certain elements 
that would otherwise be required. In addition, the draft guidance 
recommends documentation practices that trading partners can use to 
satisfy the requirements of section 582(b)(1), (c)(1), (d)(1), and 
(e)(1) of the FD&C Act.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA about 
standardization of data and documentation practices for the exchange of 
product tracing information. 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. This guidance is not subject to Executive 
Order 12866.

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 (PRA) (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 modifications to those previously approved 
collections of information found in FDA regulations or guidances.

III. Electronic Access

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

    Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04180 Filed 3-1-18; 8:45 am]
BILLING CODE 4164-01-P


