Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation, 23050-23051 [2020-08766]
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23050
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
As reflected in table 1, row 6, we
estimate 70 submissions under the
PLAIR program. Since implementation
of PLAIR there has been significant
interest. We have therefore doubled our
original estimate of 35 to 70 respondents
annually but retain the average burden
per response of 16 hours to provide the
information recommended in the draft
guidance.
Cumulatively these changes and
adjustments result in a reduction in
annual responses by 40,111,035 and an
increase in burden hours by 130,572.
These changes and adjustments reflect
the realization of one-time burden
associated with conforming to new CBP
electronic reporting requirements since
last OMB approval of the information
collection that we believe no longer
applies. Finally, we consolidated related
information collection activities
associated with CFR part 1, subparts D
(§§ 1.70 through 1.81) and E (§§ 1.83
through 1.101) governing FDA import
activities.
Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–08763 Filed 4–23–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:03 Apr 23, 2020
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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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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
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23051
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
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
responses per
respondent
Number of
respondents
Respondent activity
Average
burden per
response
Total annual
responses
Total
hours
Requests to FDA for a Waiver, Exception, or Exemption ...........
Notifications to FDA of a Material Change in Circumstances
Warranting the Waiver, Exception, or Exemption ....................
Requests to FDA to Renew a Waiver, Exception, or Exemption
20
1
20
80
1,600
1
1
1
1
1
1
16
16
16
16
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0278]
Agency Information Collection
Request; 60-Day Public Comment
Request
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
SUMMARY:
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 23, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0278–
60D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden. Information
Collection Request Title: 0990–0278—
Federalwide Assurance Form.
Abstract: Assistant Secretary for
Health, Office for Human Research
Protections is requesting a three year
extension of the Federalwide Assurance
(FWA). The FWA is designed to provide
a simplified procedure for institutions
engaged in HHS-conducted or
supported research to satisfy the
assurance requirements of Section
491(a) of the Public Health Service Act
and HHS Regulations for the protection
of human subjects at 45 CFR 46.103.
Likely Respondents: Institutions
engaged in human subjects research that
is conducted or supported by HHS.
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Hours per
response
Response
burden hours
Federalwide Assurance (FWA) ........................................................................
14,000
2.0
30/60
14,000
Dated: April 20, 2020.
Sherrette A. Funn,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2020–08702 Filed 4–23–20; 8:45 am]
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BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism, May 12, 2020, 12:30 p.m. to
May 13, 2020, 3:00 p.m., National
Institutes of Health, National Institute
on Alcohol Abuse and Alcoholism,
6700B Rockledge Drive, Bethesda, MD
VerDate Sep<11>2014
17:03 Apr 23, 2020
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PO 00000
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20817 which was published in the
Federal Register on April 10, 2020, 85
FR 20285.
This notice is being amended to
change the start time of the closed
session on May 12, 2020, from 12:30
p.m. to 12:00 p.m. The closed session
will now be held from 12:00 p.m. to
1:00 p.m. The meeting is partially
closed to the public.
Dated: April 21, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–08779 Filed 4–23–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[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,
[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\
----------------------------------------------------------------------------------------------------------------
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
