83 FR 14643 - Agency Information Collection Request. 60-Day Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 66 (April 5, 2018)
Federal Register Volume 83, Issue 66 (April 5, 2018)
| Page Range | 14643-14644 | |
| FR Document | 2018-06959 |
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)] [Notices] [Pages 14643-14644] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06959] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS-0990-0438] Agency Information Collection Request. 60-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 June 4, 2018. 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 0990-0438-60D and project title for reference, to Sherrette.funn@hhs.gov, or call the Reports Clearance Officer. 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: Teen Pregnancy Prevention Performance Measures Data Collection, Office of Adolescent Health. Type of Collection: Revision. OMB No.: 0990-0438. Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS) is requesting approval by OMB on a revision of the Teen Pregnancy Prevention (TPP) Performance Measures from funded grantees. The performance measures data include grantee- level measures (dissemination, partners, [[Page 14644]] training, sustainability), and program-level data (reach, dosage, fidelity and quality). The data collection will provide OAH with the data needed to comply with accountability and federal performance requirements for the 1993 Government Performance and Results Act (Pub. L. 103-62); it will inform stakeholders of progress in meeting the goals of the program and of sustainability efforts; it will provide OAH with metrics for monitoring TPP grantees and it will facilitate grantees' continuous quality improvement in program implementation. Clearance is requested for three years. The likely respondents would be the estimated 85 TPP grantees. TPP grantees will report all of the data to OAH twice per year. Annualized Burden Hour Table ---------------------------------------------------------------------------------------------------------------- Number of Forms (if necessary) Respondents (if Number of responses per Average burden Total burden necessary) respondents respondents per response hours ---------------------------------------------------------------------------------------------------------------- Grantee-level measures........ TPP grantees.... 85 2 1 170 Program-level Measures........ TPP grantees.... 85 2 372/60 1054 --------------------------------------------------------------------------------- Total..................... ................ .............. 4 .............. 1224 ---------------------------------------------------------------------------------------------------------------- Dated: March 30, 2018. Terry S. Clark, Asst. Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2018-06959 Filed 4-4-18; 8:45 am] BILLING CODE 4168-11-P
![Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices 14643
the claimed confidential information, in pharmacokinetics and bioavailability, Dated: March 29, 2018.
its consideration of comments. The and labeling documentation for Leslie Kux,
second copy, which will have the liposome drug products submitted in Associate Commissioner for Policy.
claimed confidential information NDAs and ANDAs reviewed by CDER. [FR Doc. 2018–06926 Filed 4–4–18; 8:45 am]
redacted/blacked out, will be available Although this guidance does not intend BILLING CODE 4164–01–P
for public viewing and posted on to provide recommendations specific to
https://www.regulations.gov. Submit liposome drug products to be marketed
both copies to the Dockets Management under biologics license applications DEPARTMENT OF HEALTH AND
Staff. If you do not wish your name and (BLAs), many scientific principles HUMAN SERVICES
contact information to be made publicly described in this guidance may also
apply to these products. [Document Identifier: OS–0990–0438]
available, you can provide this
information on the cover sheet and not In the Federal Register of August 21,
2002 (67 FR 54220), FDA announced the Agency Information Collection
in the body of your comments and you Request. 60-Day Public Comment
must identify this information as availability of a draft version of this
guidance. FDA published a revised draft Request
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed guidance on October 30, 2015 (80 FR AGENCY: Office of the Secretary, HHS.
except in accordance with 21 CFR 10.20 66906), because of the need to address ACTION: Notice.
and other applicable disclosure law. For changes in technology since the draft
more information about FDA’s posting was first published in 2002, and to add SUMMARY: In compliance with the
of comments to public dockets, see 80 ANDAs to the scope. Most of the requirement of the Paperwork
FR 56469, September 18, 2015, or access changes to the 2015 revised draft Reduction Act of 1995, the Office of the
the information at: https://www.gpo.gov/ guidance were made to clarify Secretary (OS), Department of Health
fdsys/pkg/FR-2015-09-18/pdf/2015- statements in the 2002 draft guidance. and Human Services, is publishing the
23389.pdf. FDA received comments in response to following summary of a proposed
Docket: For access to the docket to the draft and revised draft guidance, and collection for public comment.
read background documents or the this guidance reflects FDA’s careful DATES: Comments on the ICR must be
electronic and written/paper comments consideration of those comments. received on or before June 4, 2018.
received, go to https:// The guidance does not provide ADDRESSES: Submit your comments to
www.regulations.gov and insert the recommendations on clinical efficacy Sherrette.Funn@hhs.gov or by calling
docket number, found in brackets in the and safety studies, nonclinical (202) 795–7714.
heading of this document, into the pharmacology and/or toxicology
FOR FURTHER INFORMATION CONTACT:
‘‘Search’’ box and follow the prompts studies, liposome formulations of
When submitting comments or
and/or go to the Dockets Management vaccine adjuvants or biologics, or drug-
requesting information, please include
Staff, 5630 Fishers Lane, Rm. 1061, lipid complexes.
This guidance is being issued the document identifier 0990–0438–60D
Rockville, MD 20852. and project title for reference, to
You may submit comments on any consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Sherrette.funn@hhs.gov, or call the
guidance at any time (see 21 CFR Reports Clearance Officer.
10.115(g)(5)). The guidance represents the current
thinking of FDA on ‘‘Liposome Drug SUPPLEMENTARY INFORMATION: Interested
Submit written requests for single persons are invited to send comments
copies of this guidance to the Division Products: Chemistry, Manufacturing,
and Controls; Human Pharmacokinetics regarding this burden estimate or any
of Drug Information, Center for Drug other aspect of this collection of
Evaluation and Research, Food and and Bioavailability; and Labeling
Documentation.’’ It does not establish information, including any of the
Drug Administration, 10001 New following subjects: (1) The necessity and
Hampshire Ave., Hillandale Building, any rights for any person and is not
binding on FDA or the public. You can utility of the proposed information
4th Floor, Silver Spring, MD 20993– collection for the proper performance of
0002. Send one self-addressed adhesive use an alternative approach if it satisfies
the requirements of the applicable the agency’s functions; (2) the accuracy
label to assist that office in processing of the estimated burden; (3) ways to
your requests. See the SUPPLEMENTARY statutes and regulations. This guidance
is not subject to Executive Order 12866. enhance the quality, utility, and clarity
INFORMATION section for electronic
of the information to be collected; and
access to the guidance document. II. The Paperwork Reduction Act of (4) the use of automated collection
FOR FURTHER INFORMATION CONTACT: 1995 techniques or other forms of information
Richard T. Lostritto, Center for Drug This guidance refers to previously technology to minimize the information
Evaluation and Research, Food and approved collections of information that collection burden.
Drug Administration, 10903 New are subject to review by the Office of Title of the Collection: Teen
Hampshire Ave., Bldg. 51, Rm. 4132, Management and Budget (OMB) under Pregnancy Prevention Performance
Silver Spring, MD 20993–0002, 301– the Paperwork Reduction Act of 1995 Measures Data Collection, Office of
796–1697. (44 U.S.C. 3501–3520). The collections Adolescent Health.
SUPPLEMENTARY INFORMATION: of information in 21 CFR part 314 have Type of Collection: Revision.
been approved under OMB control OMB No.: 0990–0438.
I. Background Abstract: The Office of Adolescent
number 0910–0001.
FDA is announcing the availability of Health (OAH), U.S. Department of
III. Electronic Access
amozie on DSK30RV082PROD with NOTICES
a guidance for industry entitled Health and Human Services (HHS) is
‘‘Liposome Drug Products: Chemistry, Persons with access to the internet requesting approval by OMB on a
Manufacturing, and Controls; Human may obtain the document at either revision of the Teen Pregnancy
Pharmacokinetics and Bioavailability; https://www.fda.gov/Drugs/Guidance Prevention (TPP) Performance Measures
and Labeling Documentation.’’ This ComplianceRegulatoryInformation/ from funded grantees. The performance
guidance provides recommendations to Guidances/default.htm or https:// measures data include grantee-level
applicants on the CMC, human www.regulations.gov. measures (dissemination, partners,
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![14644 Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices
training, sustainability), and program- Act (Pub. L. 103–62); it will inform program implementation. Clearance is
level data (reach, dosage, fidelity and stakeholders of progress in meeting the requested for three years.
quality). The data collection will goals of the program and of The likely respondents would be the
provide OAH with the data needed to sustainability efforts; it will provide estimated 85 TPP grantees. TPP grantees
comply with accountability and federal OAH with metrics for monitoring TPP will report all of the data to OAH twice
performance requirements for the 1993 grantees and it will facilitate grantees’
per year.
Government Performance and Results continuous quality improvement in
ANNUALIZED BURDEN HOUR TABLE
Number of Average
Forms Respondents Number of Total burden
responses per burden per
(if necessary) (if necessary) respondents hours
respondents response
Grantee-level measures .................... TPP grantees ................................... 85 2 1 170
Program-level Measures ................... TPP grantees ................................... 85 2 372/60 1054
Total ........................................... ........................................................... ........................ 4 ........................ 1224
Dated: March 30, 2018. DEPARTMENT OF HEALTH AND number 1–888–928–9713, passcode
Terry S. Clark, HUMAN SERVICES 7160920.
Asst. Paperwork Reduction Act Reports The public comment section is
Clearance Officer, Office of the Secretary. Substance Abuse and Mental Health scheduled for 1:00 p.m. Eastern Daylight
[FR Doc. 2018–06959 Filed 4–4–18; 8:45 am]
Services Administration Time (EDT), and individuals interested
in submitting a comment, must notify
BILLING CODE 4168–11–P Notice of Meeting for the the Designated Federal Official (DFO),
Interdepartmental Serious Mental Ms. Pamela Foote, on or before May 24,
Illness Coordinating Committee 2018 via email to: Pamela.Foote@
DEPARTMENT OF HEALTH AND (ISMICC)
HUMAN SERVICES samhsa.hhs.gov.
AGENCY: Substance Abuse and Mental Two minutes will be allotted for each
National Institutes of Health Health Services Administration, approved public comment as time
Department of Health and Human permits. Written comments received in
National Library of Medicine; Services. advance of the meeting will be included
Amended; Notice of Meeting in the official record of the meeting.
ACTION: Notice.
Substantive meeting information and
Notice is hereby given of a change in SUMMARY: The Secretary of Health and a roster of Committee members is
the meeting of the Board of Regents of Human Services (Secretary), in available at the Committee’s website
the National Library of Medicine, May accordance with section 6031 of the 21st https://www.samhsa.gov/about-us/
8, 2018, 9:00 a.m. to May 9, 2018, 12:00 Century Cures Act, announces a meeting advisory-councils/smi-committee.
p.m., National Library of Medicine, of the Interdepartmental Serious Mental SUPPLEMENTARY INFORMATION:
Building 38, 2nd Floor, The Donald A.B. Illness Coordinating Committee I. Background and Authority
Lindberg Room, 8600 Rockville Pike, (ISMICC).
Bethesda, MD, 20892 which was The meeting is open to the public and The ISMICC was established on
published in the Federal Register on will include information on federal March 15, 2017, in accordance with
March 7, 2018, 83 FR 45 Page 9746. efforts related to serious mental illness section 6031 of the 21st Century Cures
(SMI) and serious emotional disturbance Act, and the Federal Advisory
The meeting will be open to the Committee Act, 5 U.S.C. App., as
public on May 9, 2018 from 9:00 a.m. (SED), including data evaluation, and
recommendations for action. Committee amended, to report to the Secretary,
to 10:30 a.m. and will then be closed Congress, and any other relevant federal
members will also discuss ISMICC
from 10:30 a.m. to 12:00 p.m., to review department or agency on advances in
member relationship to implementation
intramural programs and projects. The workgroups, establishing the prevalence serious mental illness (SMI) and serious
meeting is partially closed to the public. of SMI and SED, communication with emotional disturbance (SED), research
Dated: March 30, 2018. non-federal organizations to engage non- related to the prevention of, diagnosis
Michelle D. Trout, federal support for ISMICC, and future of, intervention in, and treatment and
meetings. recovery of SMIs, SEDs, and advances in
Program Analyst, Office of Federal Advisory
Committee Name: Interdepartmental access to services and support for adults
Committee Policy.
Serious Mental Illness Coordinating with SMI or children with SED. In
[FR Doc. 2018–06898 Filed 4–4–18; 8:45 am]
Committee. addition, the ISMICC will evaluate the
BILLING CODE 4140–01–P effect federal programs related to serious
DATE/TIME: June 8, 2018/9:00 a.m.–5:00 mental illness have on public health,
p.m. (EDT). including public health outcomes such
amozie on DSK30RV082PROD with NOTICES
ADDRESSES: The meeting will be held at as (A) rates of suicide, suicide attempts,
the Hubert H. Humphrey Building, 200 incidence and prevalence of SMIs,
Independence Avenue SW, Room 800, SEDs, and substance use disorders,
Washington, DC 20201. overdose, overdose deaths, emergency
The meeting can be accessed via hospitalizations, emergency room
webcast at www.hhs.gov/live, or by boarding, preventable emergency room
joining the teleconference at toll-free visits, interaction with the criminal
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Document Created: 2018-11-01 09:13:59
Document Modified: 2018-11-01 09:13:59
| 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 June 4, 2018. | |
| Contact | When submitting comments or requesting information, please include the document identifier 0990-0438-60D and project title for reference, to [email protected], or call the Reports Clearance Officer. | |
| FR Citation | 83 FR 14643 |
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