83 FR 42131 - Agency Information Collection Request; 30-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 161 (August 20, 2018)
Federal Register Volume 83, Issue 161 (August 20, 2018)
| Page Range | 42131-42132 | |
| FR Document | 2018-17812 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Notices] [Pages 42131-42132] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17812] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-0438] 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 September 19, 2018. 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: Office of Adolescent Health Teen Pregnancy Prevention, FY 2015-2020 Performance Measure Collection. Type of Collection: Extension. OMB No. 0990-0438. Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS), is requesting renewal by OMB of the existing information collection request for performance measures collection from the TPP grant recipients. Performance measure data collection is a requirement of TPP grants; the extension will allow for the completion of data collection from cohort 2. The collection will provide OAH with performance data to inform planning decisions; identify technical assistance needs for grantees; facilitate grantees' continuous quality improvement in program implementation; and provide HHS, Congress, OMB, and the general public with information about the individuals who participate in TPP-funded activities. Estimated Annualized Burden Table ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- Grant Recipient--Dissemination Form.......... 84 2 15/60 42 Grant Recipient--Partnerships Form........... 84 2 15/60 42 [[Page 42132]] Grant Recipient--Facilitator Training Form... 84 2 15/60 42 Grant Recipient--Healthcare Linkages Form.... 84 2 15/60 42 Grant Recipient: Participant Reach Form...... 84 2 168/60 470 Grant Recipient: Dosage Form................. 84 2 102/60 286 Grant Recipient Fidelity Form................ 84 2 102/60 286 Grant Recipient: Cost Form................... 84 1 30/60 42 ------------------------------------------------------------------ Total.................................... .............. .............. .............. 1252 ---------------------------------------------------------------------------------------------------------------- Terry Clark, Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 2018-17812 Filed 8-17-18; 8:45 am] BILLING CODE 4168-11-P
![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42131
protocols in fiscal year (FY) 2017, under The estimated total annual responses regulations, the average burden per
the regulations cited previously in this are based on FDA’s final actions response is based on the higher end of
document. FDA estimates that completed in FY 2017 for the various the estimate (rounded to 5 or 6 hours)
approximately 75 manufacturers submission requirements of samples since more information is generally
submitted protocols under § 610.2 and 2 and protocols for the licensed biological required to be submitted in the other
manufacturers submitted protocols products. The average burden per protocols than under § 610.2.
under the regulation (§ 660.6) for the response is based on information In the Federal Register of May 11,
other specific product. FDA received no provided by industry. The burden 2018, (83 FR 22081), we published a
submissions under §§ 660.36 or 660.46; estimates provided by industry ranged notice soliciting public comment of the
however, FDA is using the estimate of from 1 to 5.5 hours. Under § 610.2, the information collection. No comments
one protocol submission under each hours per response are based on the were received.
regulation in the event that protocols are average of these estimates and rounded We therefore estimate the burden of
submitted in the future. to 3 hours. Under the remaining the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity responses per burden per Total hours
respondents responses
respondent response
610.2—Requests for Samples and Protocols; Official Re-
lease ................................................................................. 75 86.267 6,470 3 19,410
660.6(b)—Protocols ............................................................. 2 3.5 7 5 35
660.36(a)(2) and (b)—Samples and Protocols .................... 1 1 1 6 6
660.46(b)—Protocols ........................................................... 1 1 1 5 5
Total .............................................................................. ........................ ........................ ........................ ........................ 19,456
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the and Human Services, is publishing the techniques or other forms of information
information collection reflects an following summary of a proposed technology to minimize the information
overall increase of 764 hours and a collection for public comment. collection burden.
corresponding increase of 262 DATES: Comments on the ICR must be Title of the Collection: Office of
responses. We attribute this adjustment received on or before September 19, Adolescent Health Teen Pregnancy
to an increase in the number of 2018. Prevention, FY 2015–2020 Performance
submissions we received over the last Measure Collection.
few years. ADDRESSES: Submit your comments to
Type of Collection: Extension.
OIRA_submission@omb.eop.gov or via
Dated: August 14, 2018. OMB No. 0990–0438.
facsimile to (202) 395–5806.
Leslie Kux, Abstract: The Office of Adolescent
FOR FURTHER INFORMATION CONTACT:
Associate Commissioner for Policy. Health (OAH), U.S. Department of
Sherrette Funn, Sherrette.Funn@hhs.gov Health and Human Services (HHS), is
[FR Doc. 2018–17859 Filed 8–17–18; 8:45 am] or (202) 795–7714. When submitting requesting renewal by OMB of the
BILLING CODE 4164–01–P comments or requesting information, existing information collection request
please include the document identifier for performance measures collection
0990–New–30D and project title for from the TPP grant recipients.
DEPARTMENT OF HEALTH AND reference.
HUMAN SERVICES Performance measure data collection is
SUPPLEMENTARY INFORMATION: Interested a requirement of TPP grants; the
[Document Identifier: OS–0990–0438] persons are invited to send comments extension will allow for the completion
regarding this burden estimate or any of data collection from cohort 2. The
Agency Information Collection other aspect of this collection of collection will provide OAH with
Request; 30-Day Public Comment information, including any of the performance data to inform planning
Request following subjects: (1) The necessity and decisions; identify technical assistance
AGENCY: Office of the Secretary, HHS utility of the proposed information needs for grantees; facilitate grantees’
ACTION: Notice. collection for the proper performance of continuous quality improvement in
the agency’s functions; (2) the accuracy program implementation; and provide
SUMMARY: In compliance with the of the estimated burden; (3) ways to HHS, Congress, OMB, and the general
requirement of the Paperwork enhance the quality, utility, and clarity public with information about the
Reduction Act of 1995, the Office of the of the information to be collected; and individuals who participate in TPP-
Secretary (OS), Department of Health (4) the use of automated collection funded activities.
ESTIMATED ANNUALIZED BURDEN TABLE
daltland on DSKBBV9HB2PROD with NOTICES
Average
Number of
Number of burden Total burden
Type of respondent responses per
respondents per response hours
respondent (in hours)
Grant Recipient—Dissemination Form ...................................................... 84 2 15/60 42
Grant Recipient—Partnerships Form ........................................................ 84 2 15/60 42
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![42132 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Average
Number of
Number of burden Total burden
Type of respondent responses per
respondents per response hours
respondent (in hours)
Grant Recipient—Facilitator Training Form ............................................... 84 2 15/60 42
Grant Recipient—Healthcare Linkages Form ............................................ 84 2 15/60 42
Grant Recipient: Participant Reach Form .................................................. 84 2 168/60 470
Grant Recipient: Dosage Form .................................................................. 84 2 102/60 286
Grant Recipient Fidelity Form .................................................................... 84 2 102/60 286
Grant Recipient: Cost Form ....................................................................... 84 1 30/60 42
Total .................................................................................................... ........................ ........................ ........................ 1252
Terry Clark, Secretary, in consultation with the Comment’’ in the subject line. The
Office of the Secretary, Asst Paperwork Secretary of the U.S. Department of NACCD Chair will respond to comments
Reduction Act Reports Clearance Officer. Homeland Security, established the received by September 10, 2018, during
[FR Doc. 2018–17812 Filed 8–17–18; 8:45 am] NACCD. The purpose of the NACCD is the public teleconference.
BILLING CODE 4168–11–P to provide advice and consultation to Dated: August 13, 2018.
the HHS Secretary with respect to the Robert P. Kadlec,
medical and public health needs of
Assistant Secretary for Preparedness and
DEPARTMENT OF HEALTH AND children in relation to disasters. Response.
HUMAN SERVICES Background: The September 11, 2018,
[FR Doc. 2018–17901 Filed 8–17–18; 8:45 am]
public teleconference of the NACCD is
National Advisory Committee on BILLING CODE 4150–28–P
dedicated to the presentation,
Children and Disasters Public deliberation, and vote on the Pediatric
Teleconference Disaster Training Work Group (PDTWG)
DEPARTMENT OF HEALTH AND
and Identifying Metrics of Baseline
AGENCY: Office of the Assistant HUMAN SERVICES
Vulnerability (IMBV) reports.
Secretary for Preparedness and
Established under the NACCD in 2017, National Advisory Committee on
Response (ASPR), Department of Health
the PDTWG met several times over the Children and Disasters and National
and Human Services (HHS).
past year to evaluate progress since the Biodefense Science Board Public
ACTION: Notice. 2011 National Center for Disaster Teleconference
SUMMARY: As stipulated by the Federal Medicine and Public Health consensus
report and to develop recommendations AGENCY: Office of the Assistant
Advisory Committee Act, the
to further improve pediatric training to Secretary for Preparedness and
Department of Health and Human
ensure the safety and health of children Response (ASPR), Department of Health
Services is hereby giving notice that the
in disasters. Separately, in 2018, the and Human Services (HHS).
National Advisory Committee on
ASPR identified metrics of baseline ACTION: Notice.
Children and Disasters (NACCD) will
hold a public teleconference on community vulnerability as a topic he
SUMMARY: As stipulated by the Federal
September 11, 2018. would like the NACCD to address and
Advisory Committee Act, the
provide recommendations. On June 28,
DATES: The NACCD Public Department of Health and Human
2018, the NACCD met publically and in-
Teleconference is September 11, 2018, Services is hereby giving notice that the
person to develop metrics via a
from 2:00 p.m. to 3:00 p.m. Eastern National Advisory Committee on
facilitated discussion. Takeaways from
Daylight Time (EDT). Children and Disasters (NACCD) and
this discussion served as the basis for
ADDRESSES: We encourage members of National Biodefense Science Board
the IMBV report. We will post
the public to attend the public meetings. (NBSB), also known as the National
modifications to the agenda on the
To register, send an email to naccd@ Preparedness and Response Science
NACCD meeting website, which is
hhs.gov with ‘‘NACCD Registration’’ in Board (NPRSB), will hold a joint public
located at https://www.phe.gov/naccd.
the subject line. Submit your comments Availability of Materials: We will post teleconference on September 12, 2018.
to naccd@hhs.gov or via the NACCD all teleconference materials prior to the DATES: The NBSB and NACCD Joint
Contact Form located at https:// teleconference on September 11, 2018, Public Teleconference is September 12,
www.phe.gov/Preparedness/legal/ at the website located at https:// 2018, from 2:00 p.m. to 3:00 p.m.
boards/naccd/Pages/contact.aspx. For www.phe.gov/naccd. Eastern Daylight Time (EDT).
additional information, visit the NACCD Procedures for Providing Public Input: ADDRESSES: We encourage members of
website located at https://www.phe.gov/ Members of the public may attend the the public to attend the public meetings.
naccd. public teleconference via a toll-free call- To register, send an email to naccd@
SUPPLEMENTARY INFORMATION: Pursuant in phone number, which is available on hhs.gov with ‘‘NACCD Registration’’ in
to the Federal Advisory Committee Act the NACCD website at https:// the subject line, or to nprsb@hhs.gov
daltland on DSKBBV9HB2PROD with NOTICES
of 1972 (5 U.S.C., Appendix, as www.phe.gov/naccd. with ‘‘NBSB Registration’’ in the subject
amended), and Section 2811A of the We encourage members of the public line. Submit your comments to naccd@
Public Health Service (PHS) Act (42 to provide written comments that are hhs.gov, nprsb@hhs.gov, the NBSB
U.S.C. 300hh–10a), as added by Section relevant to the NACCD public Contact Form located at https://
103 of the Pandemic and All-Hazards teleconference prior to September 11, www.phe.gov/Preparedness/legal/
Preparedness Reauthorization Act of 2018. Send written comments by email boards/nprsb/Pages/RFNBSBComments.
2013 (Pub. L. 113–5), the HHS to naccd@hhs.gov with ‘‘NACCD Public aspx, or the NACCD Contact Form
VerDate Sep<11>2014 19:04 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1](https://thefederalregister.org/doc/83_FR_42292/page/2.svg)
Document Created: 2018-08-18 01:29:10
Document Modified: 2018-08-18 01:29:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the ICR must be received on or before September 19, 2018. | |
| 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. | |
| FR Citation | 83 FR 42131 |
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