Agency Information Collection Request; 30-Day Public Comment Request, 30059-30060 [2021-11723]
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Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Product Identifiers Under the Drug
Supply Chain Security Act: Questions
and Answers.’’ The DSCSA (Title II of
Pub. L. 113–54) was signed into law on
November 27, 2013. Section 202 of the
DSCSA, which added sections 581 and
582 to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360eee and 360eee–1), set forth new
definitions and requirements for
manufacturers, repackagers, wholesale
distributors, and dispensers to facilitate
the tracing of product through the
pharmaceutical distribution supply
chain.
A product identifier is defined under
section 581(14) of the FD&C Act as a
standardized graphic that includes the
product’s standardized numerical
identifier (composed of the National
Drug Code and a unique alphanumeric
serial number), lot number, and
expiration date, in both human- and
machine-readable formats. Under
sections 582(b)(2)(A) and 582(e)(2) of
the FD&C Act, respectively,
manufacturers and repackagers are
required to ‘‘affix or imprint a product
identifier to each package and
homogenous case of a product intended
to be introduced in a transaction into
commerce.’’
In the Federal Register of September
20, 2018 (83 FR 47626), FDA announced
the availability of the draft guidance of
the same title dated September 20, 2018.
FDA received several comments on the
draft guidance and considered those
comments as we finalized the guidance.
Among the key substantive changes, we
revised the recommendations regarding
the expiration date format—specifically,
we no longer recommend using a space
between the day, month, and year; we
now recommend using a hyphen or
forward slash between the expiration
date elements. In addition, we also
modified our statements regarding use
of the human-readable GS1 Global
Trade Identification Number to explain
the importance of the three segment
NDC format for patient safety. We also
clarified how to affix or imprint
multiple barcodes on the label with
sufficient space to avoid confusion in
reading or scanning. We made
additional, editorial changes to improve
clarity. The guidance announced in this
notice finalizes the draft guidance dated
September 20, 2018.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Product Identifiers
VerDate Sep<11>2014
17:08 Jun 03, 2021
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Under the Supply Chain Security Act:
Questions and Answers.’’ 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.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11733 Filed 6–3–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0476]
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.
DATES: Comments on the ICR must be
received on or before July 6, 2021.
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 0990–0476, 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
SUMMARY:
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30059
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: ASPA COVID–
19 Public Education Campaign Market
Research.
Type of Collection: OMB #0990–0476.
Abstract: U. S. Department of Health
and Human Services (HHS), the Office
of the Secretary, the Office of the
Assistant Secretary for Public Affairs
(ASPA), is requesting an extension on a
currently approved collection that
includes three components: 1. COVID–
19 Current Events Tracker; 2.
Foundational Focus Groups; and 3.
Copy Testing Surveys. Together, these
efforts support the development and
execution of the COVID–19 Public
Education Campaign. The broad
purpose of each effort is as follows:
Current Events Tracker
The primary purpose of the COVID–
19 Current Events Tracker (CET) survey
is to continuously track key metrics of
importance to the Campaign, including
vaccine confidence, familiarity with and
trust in HHS, and the impact of external
events on key attitudes and behaviors.
Tracking Americans’ attitudes about,
perceptions of, and behavior toward the
COVID–19 pandemic will inform the
Campaign of key metrics around vaccine
confidence and uptake, as well as
towards vaccine messengers such as
HHS and key public health officials. It
will also inform changes in messaging
strategies necessary to effectively reach
the entire U.S. population or specific
subgroups.
The weekly tracking of this
information will be critical for the
Campaign’s ability to respond to shifting
events and attitudes in real-time,
helping guide the American public with
accurate information about the vaccine
rollout as well as on how to take
protective actions.
Foundational Focus Groups
ASPA is collecting information
through the COVID–19 Public Education
Campaign Foundational Focus Groups
to inform the Campaign about audience
risk knowledge, perceptions, current
behaviors, and barriers and motivators
to healthy behaviors (including COVID–
19 vaccination). Ultimately these focus
groups will provide in-depth insights
E:\FR\FM\04JNN1.SGM
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30060
Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices
regarding information needed by
Campaign audiences as well as their
attitudes and behaviors related to
COVID–19 and the COVID–19 vaccines.
These will be used to inform the
development of Campaign messages and
strategy.
Copy Testing Surveys
Prior to placing Campaign
advertisements in market, ASPA will
conduct copy testing surveys to ensure
the final Campaign messages have the
intended effect on target attitudes and
behaviors. Copy testing surveys will be
conducted with sample members who
comprise the target audiences; these
surveys will assess perceived
effectiveness of the advertisements as
well as the effect of exposure to an ad
on key attitudes and behavioral
intentions. The results from these
surveys will be used internally by ASPA
to inform decisions on Campaign
messages and materials; for example, to
identify revisions to the materials or
determine which advertisement to move
to market.
Need and Proposed Use: In light of
the current COVID–19 crisis, this
information is needed given the impact
of the pandemic on the nation. The
Secretary of the Department of Health
and Human Services (HHS) has declared
a public health emergency effective
January 27, 2020, under section 319 of
the Public Health Service Act (42 U.S.C.
247d [1]) and renewed it continually
since its issuance (see links to the
determination here and here).
Additionally, in accordance with 5 CFR
1320.13, HHS previously requested
emergency submissions (sections 1320
(a)(2)(ii) and (2)(iii) of the federal
regulations.
ESTIMATED ANNUALIZED BURDEN HOUR TABLE
CET
Foundational
focus groups
Copy testing
survey
Hours to screen ...........................................................................................................................
Screening completes (per wave) .................................................................................................
Screening participants (total/screened out) .................................................................................
Hours to complete survey/group .................................................................................................
Participants (per wave/round) ......................................................................................................
Number of waves/rounds .............................................................................................................
Burden per wave/round ...............................................................................................................
N/A
N/A
N/A
0.12
1,000
92
120
.09
2,500
20,000/19,136
1.5
108
8
387
0.03
6,700
53,600/45,600
0.33
1,000
8
330
Total participants ..................................................................................................................
92,000
864
8,000
Total respondents * ...............................................................................................................
92,000
20,000
53,600
Total burden hours ...............................................................................................................
11,040
3,096
4,248
* Total respondents = total participants for each effort + total people screened out.
Sum of All Studies
Total Respondents: 165,600.
Total Burden Hours: 18,384.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–11723 Filed 6–3–21; 8:45 am]
BILLING CODE 4150–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
VerDate Sep<11>2014
17:08 Jun 03, 2021
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applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Integrated Preclinical/
Clinical AIDS Vaccine Development Program
(IPCAVD) (U19 Clinical Trial Not Allowed).
Date: June 30, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G36,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Poonam Pegu, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
Fishers Lane, MSC–9823, Rockville, MD
20892, 240–292–0719, poonam.pegu@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
National Institutes of Health
Dated: May 28, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; SARS-CoV–2, COVID–19
and Consequences of Alcohol Use (RFA AA
21–002, AA 21–003 and AA21–004).
Date: July 15–16, 2021.
Time: 9:00 a.m. to 6:00 p.m.
[FR Doc. 2021–11711 Filed 6–3–21; 8:45 am]
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National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30059-30060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11723]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0476]
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 July 6, 2021.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0476, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], 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.
Title of the Collection: ASPA COVID-19 Public Education Campaign
Market Research.
Type of Collection: OMB #0990-0476.
Abstract: U. S. Department of Health and Human Services (HHS), the
Office of the Secretary, the Office of the Assistant Secretary for
Public Affairs (ASPA), is requesting an extension on a currently
approved collection that includes three components: 1. COVID-19 Current
Events Tracker; 2. Foundational Focus Groups; and 3. Copy Testing
Surveys. Together, these efforts support the development and execution
of the COVID-19 Public Education Campaign. The broad purpose of each
effort is as follows:
Current Events Tracker
The primary purpose of the COVID-19 Current Events Tracker (CET)
survey is to continuously track key metrics of importance to the
Campaign, including vaccine confidence, familiarity with and trust in
HHS, and the impact of external events on key attitudes and behaviors.
Tracking Americans' attitudes about, perceptions of, and behavior
toward the COVID-19 pandemic will inform the Campaign of key metrics
around vaccine confidence and uptake, as well as towards vaccine
messengers such as HHS and key public health officials. It will also
inform changes in messaging strategies necessary to effectively reach
the entire U.S. population or specific subgroups.
The weekly tracking of this information will be critical for the
Campaign's ability to respond to shifting events and attitudes in real-
time, helping guide the American public with accurate information about
the vaccine rollout as well as on how to take protective actions.
Foundational Focus Groups
ASPA is collecting information through the COVID-19 Public
Education Campaign Foundational Focus Groups to inform the Campaign
about audience risk knowledge, perceptions, current behaviors, and
barriers and motivators to healthy behaviors (including COVID-19
vaccination). Ultimately these focus groups will provide in-depth
insights
[[Page 30060]]
regarding information needed by Campaign audiences as well as their
attitudes and behaviors related to COVID-19 and the COVID-19 vaccines.
These will be used to inform the development of Campaign messages and
strategy.
Copy Testing Surveys
Prior to placing Campaign advertisements in market, ASPA will
conduct copy testing surveys to ensure the final Campaign messages have
the intended effect on target attitudes and behaviors. Copy testing
surveys will be conducted with sample members who comprise the target
audiences; these surveys will assess perceived effectiveness of the
advertisements as well as the effect of exposure to an ad on key
attitudes and behavioral intentions. The results from these surveys
will be used internally by ASPA to inform decisions on Campaign
messages and materials; for example, to identify revisions to the
materials or determine which advertisement to move to market.
Need and Proposed Use: In light of the current COVID-19 crisis,
this information is needed given the impact of the pandemic on the
nation. The Secretary of the Department of Health and Human Services
(HHS) has declared a public health emergency effective January 27,
2020, under section 319 of the Public Health Service Act (42 U.S.C.
247d [1]) and renewed it continually since its issuance (see links to
the determination here and here). Additionally, in accordance with 5
CFR 1320.13, HHS previously requested emergency submissions (sections
1320 (a)(2)(ii) and (2)(iii) of the federal regulations.
Estimated Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Foundational Copy testing
CET focus groups survey
----------------------------------------------------------------------------------------------------------------
Hours to screen................................................. N/A .09 0.03
Screening completes (per wave).................................. N/A 2,500 6,700
Screening participants (total/screened out)..................... N/A 20,000/19,136 53,600/45,600
Hours to complete survey/group.................................. 0.12 1.5 0.33
Participants (per wave/round)................................... 1,000 108 1,000
Number of waves/rounds.......................................... 92 8 8
Burden per wave/round........................................... 120 387 330
-----------------------------------------------
Total participants.......................................... 92,000 864 8,000
-----------------------------------------------
Total respondents *......................................... 92,000 20,000 53,600
-----------------------------------------------
Total burden hours.......................................... 11,040 3,096 4,248
----------------------------------------------------------------------------------------------------------------
* Total respondents = total participants for each effort + total people screened out.
Sum of All Studies
Total Respondents: 165,600.
Total Burden Hours: 18,384.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-11723 Filed 6-3-21; 8:45 am]
BILLING CODE 4150-25-P
