Submission for OMB Review; Comment Request, 17412-17413 [2019-08322]
Download as PDF
<![CDATA[
17412
Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Administration for Children and
Families
Notice of Closed Meeting
Notice of Closed Meeting
Submission for OMB Review;
Comment Request
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, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. 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.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—RFA–CE–19–002,
Research Grants to Identify Effective
Strategies for Opioid Overdose Prevention.
Date: June 25–26, 2019.
Time: 8:30 a.m.–5:30 p.m., EDT.
Place: Hilton Garden Inn Atlanta—
Buckhead, 3342 Peachtree Road NE, Atlanta,
GA 30326
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Mikel
Walters, Ph.D., Scientific Review Official,
NCIPC, CDC, 4770 Buford Highway NE,
Mailstop F–63, Atlanta, Georgia 30341,
Telephone (404) 639–0913, MWalters@
cdc.gov.
The Chief Operating Officer, Centers for
Disease Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. 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.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—PAR 18–812, NIOSH
Member Conflict.
Date: June 27, 2019.
Time: 1:00 p.m.–4:00 p.m. EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Reviewer Officer,
Office of Extramural Programs, 1095
Willowdale Road, Morgantown, WV 26506,
(304) 285–5976, nxt2@cdc.gov.
The Chief Operating Officer, Centers for
Disease Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–08338 Filed 4–24–19; 8:45 am]
[FR Doc. 2019–08337 Filed 4–24–19; 8:45 am]
BILLING CODE 4163–18–P
BILLING CODE 4163–18–P
Title: National Evaluation of the
Sexual Risk Avoidance Education
(SRAE) Program.
OMB No.: [NEW].
Description: The Administration for
Children and Families (ACF) proposes a
data collection effort related to the
National Evaluation of the Sexual Risk
Avoidance Education (SRAE) Program—
National Descriptive Study.
The National Descriptive Study (of
the National Evaluation of the SRAE
Program) has multiple components.
This information collection request only
pertains to the Early Implementation
Study, which will provide an early
catalogue of SRAE programs’
implementation. ACF seeks approval to
collect the following information:
—Survey for Use with SRAE grantees.
The purpose of this collection effort is
to conduct surveys with
administrators/program directors in
each of the states/organizations that
received SRAE grants to better
understand what key decisions states/
organizations made regarding the
design of their SRAE-funded
programs and why they made those
decisions.
—Interview Guide for Use with SRAE
grantees. The purpose of this
collection effort is to conduct semistructured interviews, that follow-on
the surveys, with administrators/
program directors in each of the
states/organizations that received
SRAE grants: the interviews will offer
long-answer, qualitative responses to
key questions, to better understand
what key decisions states/
organizations made regarding the
design of their SRAE-funded
programs and why they made those
decisions.
Respondents: State level
administrators; Agency administrators;
Organization heads; Project directors.
khammond on DSKBBV9HB2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Survey for SRAE Grantees ..................................................
Interview Guide for SRAE Grantees ....................................
VerDate Sep<11>2014
16:25 Apr 24, 2019
Jkt 247001
PO 00000
Frm 00039
Annual
number of
respondents
85
85
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
28
28
E:\FR\FM\25APN1.SGM
1
1
25APN1
Average
burden hours
per response
1.5
1.5
Annual
burden
hours
42
42
Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Notices
Estimated Total Annual Burden
Hours: 84 hours.
Additional Information: Copies of the
proposed collection may be obtained by
emailing OPREinfocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
OMB Comment: 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. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–08322 Filed 4–24–19; 8:45 am]
BILLING CODE 4184–83–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0762]
Extending Expiration Dates of
Doxycycline Tablets and Capsules in
Strategic Stockpiles; Guidance for
Government Public Health and
Emergency Response Stakeholders;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for government public health
and emergency response stakeholders
entitled ‘‘Extending Expiration Dates of
Doxycycline Tablets and Capsules in
Strategic Stockpiles.’’ This document
provides guidance to government
stakeholders on testing to extend the
expiration date—under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act)—of stockpiled doxycycline tablets
and capsules for public health
emergency preparedness and response
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:25 Apr 24, 2019
Jkt 247001
purposes for an anthrax emergency.
This guidance has been prepared in
response to requests from States asking
FDA what would be necessary to
provide confidence that stockpiled
doxycycline tablets and capsules have
retained their original quality beyond
the manufacturer’s labeled expiration
date so the replacement of stockpiled
product could be deferred. This
guidance and any resulting expiration
date extensions authorized by FDA do
not apply to doxycycline available
commercially or otherwise held for any
other nonemergency purpose. This
guidance finalizes the draft guidance
issued in April 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on April 25, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
17413
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–0762 for ‘‘Extending Expiration
Dates of Doxycycline Tablets and
Capsules in Strategic Stockpiles.’’
Received comments 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Notices]
[Pages 17412-17413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08322]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: National Evaluation of the Sexual Risk Avoidance Education
(SRAE) Program.
OMB No.: [NEW].
Description: The Administration for Children and Families (ACF)
proposes a data collection effort related to the National Evaluation of
the Sexual Risk Avoidance Education (SRAE) Program--National
Descriptive Study.
The National Descriptive Study (of the National Evaluation of the
SRAE Program) has multiple components. This information collection
request only pertains to the Early Implementation Study, which will
provide an early catalogue of SRAE programs' implementation. ACF seeks
approval to collect the following information:
--Survey for Use with SRAE grantees. The purpose of this collection
effort is to conduct surveys with administrators/program directors in
each of the states/organizations that received SRAE grants to better
understand what key decisions states/organizations made regarding the
design of their SRAE-funded programs and why they made those decisions.
--Interview Guide for Use with SRAE grantees. The purpose of this
collection effort is to conduct semi-structured interviews, that
follow-on the surveys, with administrators/program directors in each of
the states/organizations that received SRAE grants: the interviews will
offer long-answer, qualitative responses to key questions, to better
understand what key decisions states/organizations made regarding the
design of their SRAE-funded programs and why they made those decisions.
Respondents: State level administrators; Agency administrators;
Organization heads; Project directors.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number Annual number responses per hours per Annual burden
of respondents of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Survey for SRAE Grantees........ 85 28 1 1.5 42
Interview Guide for SRAE 85 28 1 1.5 42
Grantees.......................
----------------------------------------------------------------------------------------------------------------
[[Page 17413]]
Estimated Total Annual Burden Hours: 84 hours.
Additional Information: Copies of the proposed collection may be
obtained by emailing [email protected]. Alternatively,
copies can also be obtained by writing to the Administration for
Children and Families, Office of Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance
Officer. All requests, emailed or written, should be identified by the
title of the information collection.
OMB Comment: 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. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
[email protected], Attn: Desk Officer for the Administration
for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-08322 Filed 4-24-19; 8:45 am]
BILLING CODE 4184-83-P
