Submission for OMB Review; Comment Request, 17412-17413 [2019-08322]

Download as PDF 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]


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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