Submission for OMB Review; Formative Data Collections for ACF Research and Evaluation, 1978-1979 [2021-00209]
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1978
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
in scope. Some of the conditions listed
in this section are contraindications or
precautions to vaccination, while others
are intended to prompt the patient and
provider to ask additional questions and
investigate further.
Section 4 (‘‘Risks of a vaccine
reaction’’) sets forth adverse events that
could occur after vaccination. Included
are discussion of the risk of severe
allergic reaction and the remote
possibility of serious injury or death.
Language for this section has been
standardized across VISs to the extent
possible while still adhering to vaccinespecific information from the
recommendations of the Advisory
Committee on Immunization Practices
(ACIP).
The complete text of section 5 (‘‘What
if there I a serious problem?’’), section
6 (‘‘The National Vaccine Injury
Compensation Program’’), and section 7
(‘‘How can I learn more?’’), as proposed,
matches exactly across all of the vaccine
information materials, except for the
VIS for rotavirus vaccine which
includes additional information related
to the risk of intussusception (a very
serious adverse event that is specific to
rotavirus vaccine) in sections 5 and 6.
Text in all sections of the VISs is
updated using plain language terms and
concepts, and removing some of the
more detailed numerical and statistical
data, to make the documents more
easily understandable to the general
public. Because the vaccine information
statements are intended for patient
education, content that is relevant for
providers but not for patients is
removed. Language has been updated to
reflect a provider-neutral approach,
reflecting the fact that vaccines may be
administered by medical professionals
in a variety of specialty fields (e.g.,
using the term ‘‘health care provider’’
instead of ‘‘doctor’’ or ‘‘nurse’’).
The vaccine information materials
referenced in this notice are being
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and health
care provider groups.
We invite written comment on the
proposed vaccine information materials.
Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2021–0001). Comments
submitted will be considered in
VerDate Sep<11>2014
22:36 Jan 08, 2021
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finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
an effective date for their mandatory
use.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2021–00266 Filed 1–8–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0356]
Submission for OMB Review;
Formative Data Collections for ACF
Research and Evaluation
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) proposes
to extend data collection under the
existing overarching generic clearance
for Formative Data Collections for ACF
Research and Evaluation (OMB #0970–
0356). There are no changes to the
proposed types of information
collection or uses of data, but the
request does include an increase to the
estimated number of respondents and,
therefore, the overall burden estimate.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: ACF programs promote the
ADDRESSES:
PO 00000
Frm 00062
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economic and social well-being of
families, children, individuals, and
communities. OPRE studies ACF
programs, and the populations they
serve, through rigorous research and
evaluation projects. These include
evaluations of existing programs,
evaluations of innovative approaches to
helping low-income children and
families, research syntheses, and
descriptive and exploratory studies.
OPRE’s research serves to provide
further understanding of current
programs and service populations,
explore options for program
improvement, and assess alternative
policy and program designs. OPRE
anticipates undertaking a variety of new
research projects related to welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, family and
youth services, home visiting, child
welfare, and other areas of interest to
ACF. Under this generic clearance, ACF
engages in a variety of formative data
collections with researchers,
practitioners, technical assistance
providers, service providers, and
potential participants throughout the
field to fulfill the following goals: (1)
Inform the development of ACF
research, (2) maintain a research agenda
that is rigorous and relevant, (3) ensure
that research products are as current as
possible, and (4) inform the provision of
technical assistance. ACF uses a variety
of techniques including semi-structured
discussions, focus groups, surveys, and
telephone or in-person interviews, in
order to reach these goals.
Following standard OMB
requirements, OPRE will submit a
change request for each individual data
collection activity under this generic
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, and any supplementary
documents. OMB should review
requests within 10 days of submission.
Respondents: Example respondents
include: key stakeholder groups
involved in ACF projects and programs,
state or local government officials,
service providers, participants in ACF
programs or similar comparison groups,
experts in fields pertaining to ACF
research and programs, or others
involved in conducting ACF research or
evaluation projects.
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11JAN1
1979
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Estimated total
number of
respondents
Number of
responses per
respondent
3,000
1,500
1,125
1
1
1
Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
Estimated Total Annual Burden
Hours: 8,063
Authority: Social Security Act, Sec. 1110
[42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–00209 Filed 1–8–21; 8:45 am]
BILLING CODE 4184–79–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2635]
Potential Approach for Defining
Durations of Use for Medically
Important Antimicrobial Drugs
Intended for Use In or On Feed: A
Concept Paper; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA, we, or Agency) is
requesting comments on a document
entitled ‘‘Potential Approach for
Defining Durations of Use for Medically
Important Antimicrobial Drugs Intended
for Use In or On Feed: A Concept
Paper.’’ The concept paper outlines a
potential framework for how sponsors of
new animal drug products containing
medically important antimicrobial drugs
approved for use in or on animal feed
might voluntarily establish
appropriately defined durations of
therapeutic administration to foodproducing animals where none
currently exist. Establishing
appropriately defined durations of use
to mitigate development of
antimicrobial resistance would be
consistent with previous efforts by FDA
to protect public health by promoting
the judicious use of these drugs in foodproducing animals.
DATES: Submit either electronic or
written comments by April 12, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 12,
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:36 Jan 08, 2021
Jkt 253001
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 12, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
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Fmt 4703
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Average
burden hours
per response
2
1
.5
Annual burden
hours
6,000
1,500
563
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2635 for ‘‘Potential Approach
for Defining Durations of Use for
Medically Important Antimicrobial
Drugs Intended for Use In or On Feed:
A Concept Paper.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Pages 1978-1979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No. 0970-0356]
Submission for OMB Review; Formative Data Collections for ACF
Research and Evaluation
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) proposes to
extend data collection under the existing overarching generic clearance
for Formative Data Collections for ACF Research and Evaluation (OMB
#0970-0356). There are no changes to the proposed types of information
collection or uses of data, but the request does include an increase to
the estimated number of respondents and, therefore, the overall burden
estimate.
DATES: Comments due within 30 days of publication. OMB is required to
make a decision concerning the collection of information between 30 and
60 days after publication of this document in the Federal Register.
Therefore, a comment is best assured of having its full effect if OMB
receives it within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
SUPPLEMENTARY INFORMATION: Description: ACF programs promote the
economic and social well-being of families, children, individuals, and
communities. OPRE studies ACF programs, and the populations they serve,
through rigorous research and evaluation projects. These include
evaluations of existing programs, evaluations of innovative approaches
to helping low-income children and families, research syntheses, and
descriptive and exploratory studies. OPRE's research serves to provide
further understanding of current programs and service populations,
explore options for program improvement, and assess alternative policy
and program designs. OPRE anticipates undertaking a variety of new
research projects related to welfare, employment and self-sufficiency,
Head Start, child care, healthy marriage and responsible fatherhood,
family and youth services, home visiting, child welfare, and other
areas of interest to ACF. Under this generic clearance, ACF engages in
a variety of formative data collections with researchers,
practitioners, technical assistance providers, service providers, and
potential participants throughout the field to fulfill the following
goals: (1) Inform the development of ACF research, (2) maintain a
research agenda that is rigorous and relevant, (3) ensure that research
products are as current as possible, and (4) inform the provision of
technical assistance. ACF uses a variety of techniques including semi-
structured discussions, focus groups, surveys, and telephone or in-
person interviews, in order to reach these goals.
Following standard OMB requirements, OPRE will submit a change
request for each individual data collection activity under this generic
clearance. Each request will include the individual instrument(s), a
justification specific to the individual information collection, and
any supplementary documents. OMB should review requests within 10 days
of submission.
Respondents: Example respondents include: key stakeholder groups
involved in ACF projects and programs, state or local government
officials, service providers, participants in ACF programs or similar
comparison groups, experts in fields pertaining to ACF research and
programs, or others involved in conducting ACF research or evaluation
projects.
[[Page 1979]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Estimated
total number Number of Average Annual burden
Instrument of responses per burden hours hours
respondents respondent per response
----------------------------------------------------------------------------------------------------------------
Semi-Structured Discussions and Focus Groups.... 3,000 1 2 6,000
Interviews...................................... 1,500 1 1 1,500
Questionnaires/Surveys.......................... 1,125 1 .5 563
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 8,063
Authority: Social Security Act, Sec. 1110 [42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021-00209 Filed 1-8-21; 8:45 am]
BILLING CODE 4184-79-P
