97010 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Patient 

Access through Application 

Programming Interfaces (API); Use: This 

final rule is the first phase of policies 

centrally focused on advancing 

interoperability and patient access to 

health information using the authority 

available to the Centers for Medicare & 

Medicaid Services (CMS). We believe 

this is an important step in advancing 

interoperability, putting patients at the 

center of their health care, and ensuring 

they have electronic access to their 

health information. We are committed 

to working with stakeholders to solve 

the issue of interoperability and getting 

patients access to information about 

their health care, and we are taking an 

active approach to move participants in 

the health care market toward 

interoperability and the secure and 

timely exchange of electronic health 

information by adopting policies for the 

Medicare and Medicaid programs, the 

Children’s Health Insurance Program 

(CHIP), and qualified health plan (QHP) 

issuers on the individual market 

Federally-facilitated Exchanges (FFEs). 

For purposes of this rule, references to 

QHP issuers on the FFEs excludes 

issuers offering only stand-alone dental 

plans (SADPs). Likewise, we are also 

excluding QHP issuers only offering 

QHPs in the Federally-facilitated Small 

Business Health Options Program 

Exchanges (FF–SHOPs) from the 

provisions of this rule. This rule 

requires these impacted payers to 

maintain and use standards-based APIs 

to make certain information available to 

enrollees. CMS regulations at 42 CFR 

417.414, 417.416, 422.112(a)(1)(i), and 

422.114(a)(3)(ii) require that all 

Medicare Advantage organizations 

(MAOs) offering coordinated care plans, 

network-based private fee-for-service 

(PFFS) plans, and as well as section 

1876 cost organizations, maintain a 

network of appropriate providers that is 

sufficient to provide adequate access to 

covered services to meet the needs of 

the population served. To enforce this 

requirement, CMS regulations at 

§ 422.116 outline network adequacy 

criteria which set forth the minimum 

number of providers and maximum 

travel time and distance from enrollees 

to providers, for required provider 

specialty types in each county in the 

United States and its territories. 

Organizations must be in compliance 

with the current CMS network adequacy 

criteria guidance, which is updated and 

published annually on CMS’s website. 

This collection of information is 

essential to appropriate and timely 

compliance monitoring by CMS, in 

order to ensure that all active contracts 

offering network-based plans maintain 

an adequate network. 

This notice originally published on 

August 22, 2024 (89 FR 67943), but CMS 

was delayed in submitting it to OMB. 

For that reason, we are republishing this 

notice and the associated information 

collection request will be submitted 

upon to OMB upon publication of this 

notice. Form Number: CMS–10767 

(OMB control number: 0938–1412); 

Frequency: Occasionally; Affected 

Public: Private sector; Number of 

Respondents: 345; Number of 

Responses: 345; Total Annual Hours: 

589,950. (For policy questions regarding 

this collection contact Lorraine Doo at 

410–786–6597.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28515 Filed 12–5–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Healthy Marriage 

and Responsible Fatherhood Local 

Evaluation Final Report (New 

Collection) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, U.S. Department 

of Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Planning, 

Research, and Evaluation (OPRE) in the 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services is 

requesting approval of the Healthy 

Marriage and Responsible Fatherhood 

(HMRF) Final Report Templates. HMRF 

grant programs are required to submit a 

final report describing their local 

evaluation analyses and findings. This 

request includes guidance for grant 

recipients in the form of templates. 

Information will inform technical 

assistance to support grantees in 

developing and submitting the final 

reports to ACF to fulfill a grant 

requirement. 

DATES: Comments due January 6, 2025. 

OMB must decide about 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. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing 

OPREinfocollection@acf.hhs.gov. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 97011 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: Since 2005, Congress has 

authorized dedicated funding for 

discretionary awards from ACF’s Office 

of Family Assistance to support HMRF 

programs. Per the 2020 HMRF Notice of 

Funding Opportunities issued by ACF, 

HMRF grant recipients that are carrying 

out local evaluations are required to 

submit a final evaluation report to ACF 

at the end of their grant. The final 

reports must document the research 

questions, measures, study design, 

planned and actual implementation of 

the program, analytic methods for their 

evaluation, and evaluation findings. 

OPRE is conducting the HMRF Local 

Evaluation Technical Assistance (LETA) 

projects, jointly referred to as the 

HMRF–LETA projects, to support 

federally funded programs in evaluating 

their healthy relationship and family 

stability services to adult couples, adult 

individuals, fathers, and youth. As part 

of the HMRF–LETA project, grant 

recipients receive technical assistance to 

support planning and executing a local 

evaluation and analyzing and reporting 

local evaluation findings. 

The purpose of the current 

information collection request is to 

provide standardized report templates 

and table shells to grant recipients to 

document their evaluation’s analysis 

and findings. A structured final report 

template will facilitate grant recipients’ 

efficient and consistent reporting of 

evaluation findings in their final 

reports. The completed draft reports 

will be reviewed by the HMRF–LETA 

teams to determine whether the analysis 

and reports meet standards set by ACF, 

and to develop recommendations for 

grant recipients to improve the analysis 

and reports before final submission to 

ACF. Grant recipients will finalize and 

submit their final reports to ACF, as 

required. This request includes the time 

to develop and submit the reports. 

Respondents: The respondents are 

HMRF grant recipients conducting a 

local evaluation. There are currently 79 

grant recipients conducting local 

evaluations: 50 evaluations using 

descriptive designs (‘‘descriptive 

evaluations’’) and 29 evaluations using 

impact designs (‘‘impact evaluations’’). 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Descriptive Evaluation Final Report Template .................................... 50 1 40 2,000 

Impact Evaluation Final Report Template ........................................... 29 1 30 870 

Impact Evaluation Final Report Table Shells ...................................... 29 1 10 290 

Estimated Total Annual Burden 

Hours: 3,160. 

Authority: 42 U.S.C. 603(a)(2). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28555 Filed 12–5–24; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2033] 

Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Expedited Program for Serious 

Conditions—Accelerated Approval of 

Drugs and Biologics.’’ Accelerated 

approval is one of FDA’s expedited 

programs intended to facilitate and 

expedite development and review of 

certain drugs and biological products for 

serious or life-threatening conditions. 

This guidance provides information on 

FDA’s policies and procedures for the 

accelerated approval program, including 

discussions of which products may be 

candidates for accelerated approval, the 

standards for granting accelerated 

approval, and the procedures for 

withdrawing accelerated approval. 

When finalized, this draft guidance will 

replace the accelerated approval-related 

content in the final guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ issued on May 30, 2014 (the 

2014 final guidance). Additional 

programs to expedite product 

development are covered in the 2014 

final guidance as well as other 

guidances. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 4, 2025. to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


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