[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Notices]
[Pages 21297-21299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1434]


Waivers, Exceptions, and Exemptions From the Requirements of 
Section 582 of the Federal Food, Drug, and Cosmetic Act; Draft Guidance 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the availability of a draft guidance for industry entitled ``Waivers, 
Exceptions, and Exemptions from the Requirements of Section 582 of the 
Federal Food, Drug, and Cosmetic Act.'' When finalized, this draft 
guidance will describe the process that trading partners and 
stakeholders should use to request a waiver, exception, or exemption 
from certain requirements of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), and describe how FDA intends to review and decide such 
requests and determine FDA-initiated exceptions and exemptions. 
Additionally, when finalized, this draft guidance will describe how FDA 
intends to biennially review and renew waivers, exceptions, and 
exemptions.

DATES: Submit either electronic or written comments on the draft 
guidance by July 9, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1434 for ``Waivers, Exceptions, and Exemptions from the 
Requirements of Section 582 of the Federal Food, Drug, and Cosmetic 
Act; Draft Guidance for Industry.'' 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

[[Page 21298]]

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, or 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: Abha Kundi, 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 ``Waivers, Exceptions, and Exemptions from the Requirements of 
Section 582 of the Federal Food, Drug, and Cosmetic Act.'' The Drug 
Supply Chain Security Act (DSCSA) was signed into law on November 27, 
2013 (Title II of Pub. L. 113-54). The DSCSA outlines critical steps to 
build an electronic, interoperable system by 2023 that can identify and 
trace products as they are distributed in the United States. Section 
202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-
1), which sets forth trading partner requirements, including those 
related to product tracing, product identifiers, authorized trading 
partners, and verification. Section 582(a)(3)(A) of the FD&C Act 
directs FDA to establish processes by which: (1) An authorized trading 
partner (i.e., manufacturer, repackager, wholesale distributor, or 
dispenser) may request a waiver from certain requirements in section 
582 if it would result in an undue economic hardship or for emergency 
medical reasons; (2) a manufacturer or repackager may request an 
exception to the section 582 requirements related to product 
identifiers if a product package is too small or otherwise unable to 
accommodate a label with sufficient space; and (3) FDA may determine 
other products or transactions shall be exempt from certain 
requirements in section 582.
    Accordingly, this draft guidance describes these processes required 
by the law. Additionally, as required by section 582(a)(3)(B) of the 
FD&C Act, this draft guidance also includes a process for the biennial 
review and renewal of waivers, exceptions, and exemptions.
    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 on the process 
for waivers, exceptions, and exemptions from the requirements of 
section 582 of the FD&C 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. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), 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. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

III. Waivers, Exceptions, and Exemptions From the Requirements of 
Section 582 of the FD&C Act

    Under the draft guidance, a trading partner or stakeholder may 
request a waiver, exception, or exemption from the requirements of 
section 582 of the FD&C Act. FDA estimates that annually a total of 
approximately 20 waiver, exception, or exemption requests will be 
submitted to the Agency by approximately 20 trading partners or 
stakeholders. This estimate is based on communications the Agency has 
had with trading partners and stakeholders since the enactment of the 
DSCSA in 2013. FDA also estimates that it will take respondents an 
average of 40 hours to prepare and submit each request, including the 
time to submit any additional followup information that may be 
requested by FDA. FDA estimates that the total annual burden hours for 
submitting these requests are

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approximately 800 hours (see table 1, row 1).
    Under the draft guidance, a recipient of a waiver, exception, or 
exemption should notify FDA whenever there is a material change in the 
circumstances that were the basis for the relief. In addition, FDA 
intends to biennially review waivers, exceptions, and exemptions that 
are longer than 2 years in duration as described in the draft guidance, 
and may ask the recipients to submit information to determine whether 
there has been a material change in the circumstances.
    FDA estimates that annually it will receive approximately 1 
notification or other information from approximately 1 respondent that 
there has or has not been a material change in the circumstances that 
warranted the waiver, exception, or exemption, and that each 
notification will take approximately 16 hours to prepare and submit to 
FDA. We estimate that the total annual burden hours for submitting this 
information to FDA are approximately 16 hours (see table 1, row 2).
    Under the draft guidance, a trading partner may request that FDA 
renew a waiver, exception, or exemption that is of limited duration. 
This request should include a detailed statement justifying the 
continuance of the relief and the desired length of the extension. FDA 
estimates that annually it will receive approximately 1 renewal request 
from approximately 1 respondent, and that each request will take 
approximately 16 hours to prepare and submit to FDA. We estimate that 
the total annual burden hours for submitting these requests to FDA are 
approximately 16 hours (see table 1, row 3).

                                 Table 1--Estimated Annual Reporting Burden \1\
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    Waivers, Exceptions, and                         Number of
 Exemptions from section 582 of      Number of     responses per   Total annual   Average burden    Total hours
  the FD&C Act--Draft Guidance      respondents     respondent       responses     per response
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Requests to FDA for a Waiver,                 20               1              20              40             800
 Exception, or Exemption........
Notification to FDA of a                       1               1               1              16              16
 Material Change in
 Circumstances Warranting the
 Waiver, Exception, or Exemption
Requests to FDA to Renew a                     1               1               1              16              16
 Waiver, Exception, or Exemption
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             832
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

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

    Dated: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09843 Filed 5-8-18; 8:45 am]
 BILLING CODE 4164-01-P