81 FR 63763 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 180 (September 16, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63763-63764 | |
| FR Document | 2016-22316 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Notices] [Pages 63763-63764] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22316] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Personal Responsibility Education Program (PREP) Performance Measures and Adult Preparation Subjects (PMAPS) Studies--Data Collection Related to the Performance Measures Study. OMB No.: New Collection. Description: The Office of Planning, Research, and Evaluation (HHS/ ACF/OPRE) and the Family and Youth Services Bureau (HHS/ACF/ACYF/FYSB) in the Administration for Children and Families (ACF) propose a data collection activity as part of the Personal Responsibility Education Program (PREP) Performance Measures and Adult Preparation Subjects (PMAPS) Studies. The goals of the PMAPS studies are to collect, analyze, and report on performance measure data for PREP programs and to develop and test Adult Preparation Subjects (APS) conceptual models. The PMAPS studies consist of two components: The ``Performance Measures Study,'' and the ``Adult Preparation Subjects Study.'' This notice is specific to data collection activities for the Performance Measures Study only. The Performance Measures Study component includes collection and analysis of performance measure data from State PREP (SPREP), Tribal PREP (TPREP), Competitive PREP (CPREP), and Personal Responsibility Education Innovative Strategies (PREIS) grantees. Data will be used to determine if PREP and PREIS grantees are meeting performance benchmarks related to the program's mission and priorities. Respondents: Performance measurement data collection instruments will be administered to individuals representing SPREP, TPREP, CPREP, and PREIS grantees, their subawardees, and program participants. [[Page 63764]] 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 ---------------------------------------------------------------------------------------------------------------- Entry Survey.................. 414,747 138,249 1 0.13333......... 18,433 Exit Survey................... 331,797 110,599 1 0.25............ 27,650 Core measures................. 16,000 5,333 3 0.08............ 1,280 Performance Measures Data 279 93 2 18 for S/T; 14 3,076 Report Form (grantees). for CPREP and PREIS. Performance Measures Data 1,248 416 2 14 for S/T; 12 11,472 Report Form (sub-awardees). for CPREP. --------------------------------------------------------------------------------- Estimated Total Annual .............. .............. .............. ................ 61,911 Burden Hours. ---------------------------------------------------------------------------------------------------------------- Additional Information: Copies of the proposed collection may 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 should be identified by the title of the information collection. Email address: [email protected]. 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. Naomi Goldstein, ACF/OPRE Certifying Officer. [FR Doc. 2016-22316 Filed 9-15-16; 8:45 am] BILLING CODE 4184-37-P
![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63763
and CMS document identifier, to Redeterminations for Exchange Dated: September 13, 2016.
Paperwork@cms.hhs.gov. Participation and Insurance William N. Parham, III,
3. Call the Reports Clearance Office at Affordability Programs; Health Director, Paperwork Reduction Staff, Office
(410) 786–1326. Insurance Issuer Standards Under the of Strategic Operations and Regulatory
FOR FURTHER INFORMATION CONTACT: Affordable Care Act, Including Affairs.
Reports Clearance Office at (410) 786– Standards Related to Exchanges’’ (79 FR [FR Doc. 2016–22342 Filed 9–15–16; 8:45 am]
1326. 52994), provides that an Exchange may BILLING CODE 4120–01–P
SUPPLEMENTARY INFORMATION: Under the
choose to conduct the annual
Paperwork Reduction Act of 1995 (PRA) redetermination process for a plan year
(44 U.S.C. 3501–3520), federal agencies (1) in accordance with the existing DEPARTMENT OF HEALTH AND
must obtain approval from the Office of procedures described in 45 CFR HUMAN SERVICES
Management and Budget (OMB) for each 155.335; (2) in accordance with
procedures described in guidance Administration for Children and
collection of information they conduct
issued by the Secretary for the coverage Families
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C. year; or (3) using an alternative
proposed by the Exchange and approved Submission for OMB Review;
3502(3) and 5 CFR 1320.3(c) and Comment Request
includes agency requests or by the Secretary. The guidance
requirements that members of the public document ‘‘Guidance on Annual Title: Personal Responsibility
submit reports, keep records, or provide Redeterminations and Re-enrollment for Education Program (PREP) Performance
information to a third party. Section Marketplace Coverage for 2017’’ Measures and Adult Preparation
3506(c)(2)(A) of the PRA (44 U.S.C. contains the procedures that the
Subjects (PMAPS) Studies—Data
3506(c)(2)(A)) requires federal agencies Secretary is specifying for the 2017
Collection Related to the Performance
to publish a 30-day notice in the coverage year, as noted in (2) above.
Measures Study.
Federal Register concerning each These procedures will be adopted by the
Federally-facilitated Exchange. The final OMB No.: New Collection.
proposed collection of information, Description: The Office of Planning,
including each proposed extension or rule also amends the requirements for
product renewal and re-enrollment (or Research, and Evaluation (HHS/ACF/
reinstatement of an existing collection OPRE) and the Family and Youth
of information, before submitting the non-renewal) notices to be sent by
Qualified Health Plan (QHP) issuers in Services Bureau (HHS/ACF/ACYF/
collection to OMB for approval. To FYSB) in the Administration for
comply with this requirement, CMS is the Exchanges and specifies content for
these notices. The accompanying Children and Families (ACF) propose a
publishing this notice that summarizes data collection activity as part of the
the following proposed collection(s) of guidance document ‘‘Updated Federal
Standard Notices of Product Personal Responsibility Education
information for public comment: Program (PREP) Performance Measures
1. Type of Information Collection Discontinuation and Renewal’’ provides
standard notices for product and Adult Preparation Subjects
Request: Revision of a currently
discontinuation and renewal to be sent (PMAPS) Studies. The goals of the
approved collection; Title of
Information Collection: Annual by issuers of individual market QHPs PMAPS studies are to collect, analyze,
Eligibility Redetermination, Product and issuers in the individual market. and report on performance measure data
Discontinuation and Renewal Notices; Issuers in the small group market may for PREP programs and to develop and
Use: Section 1411(f)(1)(B) of the use the draft Federal standard small test Adult Preparation Subjects (APS)
Affordable Care Act directs the group notices released in the June 26, conceptual models.
Secretary of Health and Human Services 2014 bulletin ‘‘Draft Standard Notices The PMAPS studies consist of two
(the Secretary) to establish procedures When Discontinuing or Renewing a components: The ‘‘Performance
to redetermine the eligibility of Product in the Small Group or Measures Study,’’ and the ‘‘Adult
individuals on a periodic basis in Individual Market’’, or any forms of the Preparation Subjects Study.’’ This
appropriate circumstances. Section notice otherwise permitted by notice is specific to data collection
1321(a) of the Affordable Care Act applicable laws and regulations. States activities for the Performance Measures
provides authority for the Secretary to that are enforcing the guaranteed Study only. The Performance Measures
establish standards and regulations to renewability provisions of the Study component includes collection
implement the statutory requirements Affordable Care Act may develop their and analysis of performance measure
related to Exchanges, QHPs and other own standard notices for product data from State PREP (SPREP), Tribal
components of title I of the Affordable discontinuances, renewals, or both, PREP (TPREP), Competitive PREP
Care Act. Under section 2703 of the PHS provided the State-developed notices (CPREP), and Personal Responsibility
Act, as added by the Affordable Care are at least as protective as the Federal Education Innovative Strategies (PREIS)
Act, and former section 2712 and standard notices. Form Number: CMS– grantees. Data will be used to determine
section 2741 of the PHS Act, enacted by 10527 (OMB control number 0938– if PREP and PREIS grantees are meeting
the Health Insurance Portability and 1254); Frequency: Annually; Affected performance benchmarks related to the
Accountability Act of 1996, health Public: Private Sector, State program’s mission and priorities.
insurance issuers in the group and Governments; Number of Respondents: Respondents: Performance
individual markets must guarantee the 2,945; Total Annual Responses: 12,224; measurement data collection
renewability of coverage unless an Total Annual Hours: 149,186. (For instruments will be administered to
mstockstill on DSK3G9T082PROD with NOTICES
exception applies. The final rule policy questions regarding this individuals representing SPREP, TPREP,
‘‘Patient Protection and Affordable Care collection contact Russell Tipps at 301– CPREP, and PREIS grantees, their
Act; Annual Eligibility 492–4371). subawardees, and program participants.
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![63764 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Total Annual Number of Annual
Average burden hours per
Instrument number of number of responses per burden
response
respondents respondents respondent hours
Entry Survey ..................................... 414,747 138,249 1 0.13333 ............................................ 18,433
Exit Survey ........................................ 331,797 110,599 1 0.25 .................................................. 27,650
Core measures ................................. 16,000 5,333 3 0.08 .................................................. 1,280
Performance Measures Data Report 279 93 2 18 for S/T; 14 for CPREP and 3,076
Form (grantees). PREIS.
Performance Measures Data Report 1,248 416 2 14 for S/T; 12 for CPREP ................ 11,472
Form (sub-awardees).
Estimated Total Annual Burden ........................ ........................ ........................ ........................................................... 61,911
Hours.
Additional Information: Copies of the guidance for industry entitled such as medical information, your or
proposed collection may be obtained by ‘‘Qualification of Biomarker—Total anyone else’s Social Security number, or
writing to the Administration for Kidney Volume in Studies for confidential business information, such
Children and Families, Office of Treatment of Autosomal Dominant as a manufacturing process. Please note
Planning, Research and Evaluation, 330 Polycystic Kidney Disease.’’ This that if you include your name, contact
C Street SW., Washington, DC 20201, guidance provides a qualified context of information, or other information that
Attn: OPRE Reports Clearance Officer. use (COU) for total kidney volume identifies you in the body of your
All requests should be identified by the (TKV), measured at baseline, to be used comments, that information will be
title of the information collection. Email as a prognostic enrichment biomarker to posted on http://www.regulations.gov.
address: OPREinfocollection@ select patients with autosomal dominant • If you want to submit a comment
acf.hhs.gov. polycystic kidney disease (ADPKD) at with confidential information that you
OMB Comment: OMB is required to high risk for a ‘‘progressive decline’’ in do not wish to be made available to the
make a decision concerning the renal function, defined as a confirmed public submit the comment as a written/
collection of information between 30 30 percent decline in the patient’s paper submission and in the manner
and 60 days after publication of this estimated glomerular filtration rate detailed (see ‘‘Written/Paper
document in the Federal Register. (eGFR), for inclusion in interventional Submissions’’ and ‘‘Instructions’’).
Therefore, a comment is best assured of clinical trials. This guidance also
having its full effect if OMB receives it describes the experimental conditions Written/Paper Submissions
within 30 days of publication. Written and constraints for which this Submit written/paper submissions as
comments and recommendations for the biomarker is qualified through the follows:
proposed information collection should Center for Drug Evaluation and Research • Mail/Hand delivery/Courier (for
be sent directly to the following: Office (CDER) Biomarker Qualification written/paper submissions): Division of
of Management and Budget, Paperwork Program. This biomarker can be used by Dockets Management (HFA–305), Food
Reduction Project. Email: OIRA_ drug developers for the qualified COU and Drug Administration, 5630 Fishers
SUBMISSION@OMB.EOP.GOV. Attn: in submissions of investigational new Lane, Rm. 1061, Rockville, MD 20852.
Desk Officer for the Administration for drug applications (INDs), new drug • For written/paper comments
Children and Families. applications (NDAs), and biologics submitted to the Division of Dockets
license applications (BLAs)without the Management, FDA will post your
Naomi Goldstein,
relevant CDER review group comment, as well as any attachments,
ACF/OPRE Certifying Officer. except for information submitted,
reconsidering and reconfirming the
[FR Doc. 2016–22316 Filed 9–15–16; 8:45 am] suitability of the biomarker. marked and identified, as confidential,
BILLING CODE 4184–37–P
DATES: Submit either electronic or if submitted as detailed in
written comments on Agency guidances ‘‘Instructions.’’
at any time. Instructions: All submissions received
DEPARTMENT OF HEALTH AND must include the Docket No. FDA–
HUMAN SERVICES ADDRESSES: You may submit comment
as follows: 2015–D–2843 for ‘‘Qualification of
Biomarker—Total Kidney Volume in
Food and Drug Administration Electronic Submissions Studies for Treatment of Autosomal
[Docket No. FDA–2015–D–2843] Submit electronic comments in the Dominant Polycystic Kidney Disease;
following way: Availability.’’ Received comments will
Qualification of Biomarker—Total • Federal eRulemaking Portal: http:// be placed in the docket and, except for
Kidney Volume in Studies for www.regulations.gov. Follow the those submitted as ‘‘Confidential
Treatment of Autosomal Dominant instructions for submitting comments. Submissions,’’ publicly viewable at
Polycystic Kidney Disease; Guidance Comments submitted electronically, http://www.regulations.gov or at the
for Industry; Availability including attachments, to http:// Division of Dockets Management
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to between 9 a.m. and 4 p.m., Monday
HHS. the docket unchanged. Because your through Friday.
ACTION: Notice of availability. comment will be made public, you are • Confidential Submissions—To
solely responsible for ensuring that your submit a comment with confidential
SUMMARY: The Food and Drug comment does not include any information that you do not wish to be
Administration (FDA or Agency) is confidential information that you or a made publicly available submit your
announcing the availability of a third party may not wish to be posted, comments only as a written/paper
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Document Created: 2016-09-16 00:24:53
Document Modified: 2016-09-16 00:24:53
| 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 | |
| FR Citation | 81 FR 63763 |
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