3872 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

collection, contact Adam Pellillo at 

667–290–9621.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Blueprint for 

Approval of State-based Exchange; Use: 

The Patient Protection and Affordable 

Care Act (ACA) and its implementing 

regulations provide states with 

flexibility in the design and operation of 

Exchanges to ensure states are 

implementing Exchanges that best meet 

the needs of their consumers. States can 

choose to establish and operate a Statebased Exchange (SBE) or a State-based 

Exchange on the Federal Platform (SBE– 

FP). To ensure a state can operate a 

successful and compliant SBE or SBE– 

FP, it is critical that states provide CMS 

with a complete and thorough Exchange 

Blueprint Application, Declaration of 

Intent Letter, and attest to demonstrate 

operational readiness. The information 

collected from states will be used by 

CMS, IRS, SSA and reviewed by other 

Federal agencies to determine if a state 

can implement a complete and fully 

operational Exchange. Form Number: 

CMS–10416 (OMB control number: 

0938–1172); Frequency: Annually; 

Affected Public: State, Local, or Tribal 

governments; Number of Respondents: 

2; Total Annual Responses: 21; Total 

Annual Hours: 106. (For policy 

questions regarding this collection 

contact Tiffany Y. Animashaun at 

Tiffany.Animashaun@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2025–00695 Filed 1–14–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–71 and CMS– 

855B] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by February 14, 2025. 

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. 

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: Extension of a currently 

approved collection; Title of 

Information Collection: Quality 

Improvement Organization (QIO) 

Assumption of Responsibilities and 

Supporting Regulations; Use: The Peer 

Review Improvement Act of 1982 

amended Title XI of the Social Security 

Act to create the Utilization and Quality 

Control Peer Review Organization (PRO) 

program which replaces the Professional 

Standards Review Organization (PSRO) 

program and streamlines peer review 

activities. The term PRO has been 

renamed Quality Improvement 

Organization (QIO). This information 

collection describes the review 

functions to be performed by the QIO. 

It outlines relationships among QIOs, 

providers, practitioners, beneficiaries, 

intermediaries, and carriers. Form 

Number: CMS–R–71 (OMB control 

number: 0938–0445); Frequency: Yearly; 

Affected Public: Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 6,120; Total 

Annual Responses: 502,246; Total 

Annual Hours: 1,091,597. (For policy 

questions regarding this collection 

contact Cheryl Lehane at 617–461– 

4888.) 

2. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare 

Enrollment Application for Clinics/ 

Group Practices and Other Suppliers; 

Use: Various sections of the Act, the 

United States Code (U.S.C.), Internal 

Revenue Service (IRS) Code, and the 

CFR require providers and suppliers to 

furnish information concerning the 

amounts due and the identification of 

individuals or entities that furnish 

medical services to beneficiaries before 

payment can be made. The Form CMS– 

855B application is submitted when the 

applicant first requests Medicare 

enrollment. The application is used by 

the MACs to collect data to ensure the 

applicant has the necessary credentials 

to provide the health care services for 

which they intend to bill Medicare; this 

includes data that allows the Medicare 

contractor to correctly price, process, 

and pay the applicant’s claims. It also 

gathers information that enables MACs 

to ensure that the supplier is neither 

excluded from the Medicare program 

nor debarred, suspended, or excluded 

from any other Federal agency or 

program. The application is also used by 


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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3873 

enrolled suppliers when they are 

reporting a change in their ownership, 

a change in their current Medicare 

enrollment information, or are 

revalidating or reactivating their 

Medicare enrollment. Form Number: 

CMS–855B (OMB control number: 

0938–1377); Frequency: Occasionally; 

Affected Public: Private Sector; Business 

or other for-profits, and Not-for Profits; 

Number of Respondents: 132,800; 

Number of Responses: 132,800; Total 

Annual Hours: 155,884. (For questions 

regarding this collection, contact Frank 

Whalen at 410–786–1302 or 

Frank.Whelan@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2025–00696 Filed 1–14–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0168] 

Growing, Harvesting, Processing, and 

Distribution of Poppy Seeds—Industry 

Practices Related to Opiate Alkaloids; 

Request for Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

requesting information on industry 

practices related to poppy seeds, such as 

information about growing, harvesting, 

processing, and distribution of poppy 

seeds, including industry practices to 

reduce the opiate alkaloid content of 

poppy seeds. We are taking this action, 

in part, because we have received 

reports of adverse events related to the 

use of some poppy seed products. We 

intend to use the information to help 

determine what type(s) of actions, if 

any, we should take to help ensure that 

poppy seed products do not pose a 

health risk when consumed. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by April 15, 2025. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 15, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 

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– 

2021–P–0168 for ‘‘Growing, Harvesting, 

Processing, and Distribution of Poppy 

Seeds—Industry Practices related to 

Opiate Alkaloids; Request for 

Information.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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, 240–402–7500. 

• 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jesse Lunzer, Office of Food Chemical 

Safety, Dietary Supplements, and 

Innovation, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2879, or Holli Kubicki, Office 

of Policy, Regulations, and Information, 

Human Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is requesting information on 

industry practices related to poppy 

seeds, such as information about 

growing, harvesting, processing, and 

distribution of poppy seeds, including 

industry practices to reduce the opiate 

alkaloid content of poppy seeds. The 

opium poppy (Papaver somniferum), or 

the ‘‘poppy plant,’’ is cultivated for food 

use, decorative use, ornamental use, and 


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