Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 Pap...
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 December 14, 2026.
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.
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.
Information Collections
1.
Type of Information Collection Request:
Revision of a currently approved collection;
Title of Information Collection:
Electronic Funds Transfer Authorization Agreement; Use: Section 1815(a) of the Social Security Act provides the authority for the Secretary of Health and Human Services to pay providers/suppliers of Medicare services at such time or times as the Secretary determines appropriate (but no less frequently than monthly). Under Medicare, CMS, acting for the Secretary, contracts with Fiscal Intermediaries and Carriers to pay claims submitted by providers/suppliers who furnish services to Medicare beneficiaries. Under CMS' payment policy, Medicare providers/suppliers have the option of receiving payments electronically. The collection and verification of this information via Form CMS-588 protects our beneficiaries from illegitimate health care providers/suppliers. These procedures also protect the Medicare Trust Funds against fraud.
Form Number:
CMS-588 (OMB control number: 0938-0626);
Frequency:
Occasionally;
Affected Public:
Business or other for-profit and Not-for-profit institutions;
Number of Respondents:
59,662;
Total Annual Responses:
59,662;
Total Annual Hours:
41,293. (For policy questions regarding this collection contact Alisha Sanders at 410-786-0671.)
( printed page 73251)
2.
Type of Information Collection Request:
Extension of a currently approved collection;
Title of Information Collection:
Rebate Reduction Requests under Sections 11101 and 11102 of the Inflation Reduction Act (IRA); Use: Sections 1847A(i)(3)(G)(ii) and 1860D-14B(b)(1)(C)(ii) of the Act require CMS to reduce or waive the rebate amount for a Part B biosimilar biological product and generic Part D rebatable drug or biosimilar when CMS determines there is a severe supply chain disruption, such as a disruption caused by a natural disaster or other unique or unexpected event during a calendar quarter or applicable period, respectively. Section 1860D-14B(b)(1)(C)(iii) of the Act requires CMS to reduce or waive the rebate amount owed by a manufacturer if CMS determines that without such reduction or waiver, the manufacturer's generic Part D rebatable drug is likely to be in shortage in a subsequent applicable period. CMS will use the information submitted electronically through a secure platform by a manufacturer requesting a reduction to determine whether a Part B rebatable biosimilar product or generic Part D rebatable drug or biosimilar is eligible for a reduction in the rebate amount.
Form Number:
CMS-10858 (OMB control number: 0938-1471);
Frequency:
Yearly;
Affected Public:
Private Sector and Business or other for-profit;
Number of Respondents:
20;
Total Annual Responses:
20;
Total Annual Hours:
6,200. (For policy questions regarding this collection contact Caitlin Leach at 667-414-0802.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.
www.reginfo.gov/public/do/PRAMain
www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing
44 U.S.C. 3501-3520
5 CFR 1320.3(c)