[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23050-23051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Drug Supply Chain
Security Act Implementation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by May 26, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0806. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Drug Supply Chain Security Act Implementation OMB Control Number 0910-
0806--Revision
This information collection supports Agency implementation of
section 582 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360eee-1) (FD&C Act) as revised by the Drug Supply Chain Security Act
(DSCSA) (Pub. L. 113-54). For efficiency of Agency operations, we are
revising information collection currently approved under OMB control
number 0910-0806 pertaining to certain provisions of the DSCSA to also
include information collection activity associated with waivers,
exceptions, and exemptions from requirements. Finally, we are revising
the title of the information collection from ``Identification of
Suspect Product and Notification'' to ``Drug Supply Chain Security Act
Implementation'' to reflect the broadening scope of this information
collection request. As information collection activity is planned and
undertaken by FDA, we find consolidating related collection elements
better utilizes our resources. We have developed guidance to assist
respondents to the information collection with this topic and are
including it in the information collection accordingly.
In the Federal Register of May 9, 2018 (83 FR 21297), we published
a notice 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,'' including an
analysis and inviting public comment under the PRA regarding the
proposed information collection.
The draft guidance was issued consistent with FDA's good guidance
practice regulation (21 CFR 10.115) which provides for public comment
at any time. We intend to finalize the guidance document and are
seeking OMB approval of the attendant information collection discussed
in the document.
The most recent version of the draft guidance is available at:
https://www.fda.gov/media/113342/download.
In the 2018 NOA, we estimated that annually 20 trading partners or
stakeholders would submit approximately 20 requests for a waiver,
exception, or exemption. This estimate was based on communications we
had with trading partners and stakeholders since the 2013 enactment of
the DSCSA. We also estimated that it would require an average of 40
hours for respondents to prepare and submit each request and to submit
any additional followup information that we may request, for a total
burden of approximately 800 hours.
As described in the draft guidance, a recipient of a waiver,
exception, or exemption should notify us whenever there is a material
change in the circumstances that is the basis for the relief. In
addition, we intend to biennially review waivers, exceptions, and
exemptions that extend longer than 2 years in duration and may ask the
recipient to submit information to determine whether a material change
in the circumstances has occurred. We estimated that annually we would
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 require approximately 16
hours to prepare and submit to us, for a total of approximately 16
hours.
A trading partner may request that we 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. We estimated that annually we would
receive approximately 1 renewal request from approximately 1 respondent
and that each request would require approximately 16 hours to prepare
and submit to us, for a total of approximately 16 hours.
To address the comment that that it will require more than 40 hours
to prepare and submit requests for a waiver, exception, or exemption
from the requirements of section 582 of the FD&C Act and to submit any
additional follow up information that we may request, we increased the
estimate to 80 hours. Therefore, we now estimate that the total annual
burden hours for submitting these requests is
[[Page 23051]]
approximately 1,600 hours, for a new total of 1,632 hours (table 1).
We have therefore adjusted our estimated burden of this collection
of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Respondent activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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Requests to FDA for a Waiver, 20 1 20 80 1,600
Exception, or Exemption.............
Notifications to FDA of a Material 1 1 1 16 16
Change in Circumstances Warranting
the Waiver, Exception, or Exemption.
Requests to FDA to Renew a Waiver, 1 1 1 16 16
Exception, or Exemption.............
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Total............................ .............. .............. .............. .............. 1,632
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08766 Filed 4-23-20; 8:45 am]
BILLING CODE 4164-01-P