Agency Information Collection Request; 30-Day Public Comment Request, 70981 [2019-27753]
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70981
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
600.14; Reporting of product deviations by licensed manufacturers ......................................................................................
606.171; Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and
transfusion services ...............................................................
1271.350(b); Reporting requirements (human cells, tissues,
and cellular and tissue-based products) ...............................
1271.350(b) (CBER addendum report) .....................................
Total ...................................................................................
Number of
responses per
respondent
Number of
respondents
FDA form No.
Total
annual
responses
Average
burden per
response
Total hours
3486
93
6.14
571
2.0
1,142
3486
1,937
23.847
46,192
2.0
92,384
3486
2 3486A
93
102
2.61
22.76
243
2,322
2.0
0.25
486
580.5
........................
........................
........................
49,328
........................
94,592.5
1 There
2 Five
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of the number of respondents ((1,937 + 93) × 0.05 = 102) and total annual responses to CBER ((46,192 + 243) × 0.05 = 2,322).
Our estimated burden for the
information collection reflects an
overall increase of 739 hours and a
corresponding increase of 398
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27791 Filed 12–23–19; 8:45 am]
Comments on the ICR must be
received on or before January 27, 2020.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
BILLING CODE 4164–01–P
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.
Title of the Collection: Medical
Countermeasures.gov.
Type of Collection: OMB No. 0990–
0323—Extension—
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0323]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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
following summary of a proposed
collection for public comment.
SUMMARY:
Abstract: The Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Office of the
Biomedical Advanced Research and
Development Authority (BARDA), is
requesting an approval on an extension
by OMB on a currently approved
information collection.
The purpose of this collection is, in
order to route product developers to the
most appropriate personnel within the
Department of Health and Human
Services (HHS), HHS collects some
basic information about the company’s
product through Medical
Countermeasures.gov. Using this
information and a routing system that
has been developed with input from
participating agencies within HHS,
including the Office of the Assistant
Secretary for Preparedness and
Response (ASPR), the Centers for
Disease Control and Prevention (CDC),
the Food and Drug Administration
(FDA), and the National Institutes of
Health (NIH), Medical
Countermeasures.gov routes the meeting
request to the appropriate person within
HHS. ASPR is requesting an extension
by OMB for a three-year clearance.
Type of respondent: Developers of
medical countermeasures to naturally
occurring and intentional public health
threats visit the site on a monthly basis.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Forms
(if necessary)
Respondents
(if necessary)
Meeting Request ............
Developers of medical countermeasures to naturally occurring and
intentional public health threats.
245
1
10/60
41
Total .........................
..............................................................................................................
........................
........................
........................
41
Terry Clark,
Office of the Secretary, Asst. Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2019–27753 Filed 12–23–19; 8:45 am]
BILLING CODE 4150–04–P
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16:53 Dec 23, 2019
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Total burden
hours
]]>Agencies
[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Page 70981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27753]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0323]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before January 27,
2020.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
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.
Title of the Collection: Medical Countermeasures.gov.
Type of Collection: OMB No. 0990-0323--Extension--
Abstract: The Office of the Assistant Secretary for Preparedness
and Response (ASPR), Office of the Biomedical Advanced Research and
Development Authority (BARDA), is requesting an approval on an
extension by OMB on a currently approved information collection.
The purpose of this collection is, in order to route product
developers to the most appropriate personnel within the Department of
Health and Human Services (HHS), HHS collects some basic information
about the company's product through Medical Countermeasures.gov. Using
this information and a routing system that has been developed with
input from participating agencies within HHS, including the Office of
the Assistant Secretary for Preparedness and Response (ASPR), the
Centers for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), and the National Institutes of Health (NIH),
Medical Countermeasures.gov routes the meeting request to the
appropriate person within HHS. ASPR is requesting an extension by OMB
for a three-year clearance.
Type of respondent: Developers of medical countermeasures to
naturally occurring and intentional public health threats visit the
site on a monthly basis.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms (if necessary) Respondents (if Number of responses per Average burden Total burden
necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
Meeting Request.............. Developers of 245 1 10/60 41
medical
countermeasures
to naturally
occurring and
intentional
public health
threats.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total.................... ................. .............. .............. .............. 41
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Asst. Paperwork Reduction Act Reports
Clearance Officer.
[FR Doc. 2019-27753 Filed 12-23-19; 8:45 am]
BILLING CODE 4150-04-P
