Document ID: FDA-2014-D-0609-0031
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation
Posted Date: 2020-04-24T04:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
PRAStaff@fda.hhs.gov.

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\
----------------------------------------------------------------------------------------------------------------
                                                          Number of
         Respondent activity              Number of     responses per   Total annual   Average burden    Total
                                         respondents     respondent       responses     per response     hours
----------------------------------------------------------------------------------------------------------------
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.............
                                      --------------------------------------------------------------------------
    Total............................  ..............  ..............  ..............  ..............      1,632
----------------------------------------------------------------------------------------------------------------
\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