Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request, 26042-26043 [2021-10050]

Download as PDF 26042 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices • Meeting summary, review of recommendations, and next steps DEPARTMENT OF HEALTH AND HUMAN SERVICES Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Centers for Medicare & Medicaid Services IV. Meeting Participation Medicaid and Children’s Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). AGENCY: ACTION: Notice. On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance 1 related to the ‘‘generic’’ clearance process. Generally, this is an expedited process by which agencies may obtain OMB’s approval of collection of information requests that are ‘‘usually voluntary, low-burden, and uncontroversial collections,’’ do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938–1148 (CMS–10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates 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 SUMMARY: The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/e/apoemay-26-2021-virtual-meeting-tickets150209828641 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting. V. Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). The Acting Administrator of the Centers for Medicare & Medicaid Services (CMS), Elizabeth Richter, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. khammond on DSKJM1Z7X2PROD with NOTICES [Document Identifier: CMS–10398 #37] Dated: May 10, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2021–10118 Filed 5–11–21; 8:45 am] BILLING CODE 4120–01–P 1 https://www.whitehouse.gov/sites/ whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_ ICRs_5-28-2010.pdf. VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 minimize the information collection burden. DATES: Comments must be received by May 26, 2021. ADDRESSES: When commenting, please reference the applicable form number (see below) and the OMB control number (0938–1148). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: CMS–10398 (#37)/OMB control number: 0938–1148, Room C4– 26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may access CMS’ website at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Following is a summary of the use and burden associated with the subject information collection(s). More detailed information can be found in the collection’s supporting statement and associated materials (see ADDRESSES). Generic Information Collection 1. Title of Information Collection: Medicaid Managed Care Rate Development Guide; Type of Information Collection Request: Revision of a currently approved collection; Use: States are required to submit rate certifications for all Medicaid managed care capitation rates per 42 CFR 438.7. Our collection of information request specifies our requirements for the rate certification and details what types of documentation we expect to be included. Elements include descriptions of data used, projected benefit and nonbenefit costs, rate range development, risk and contract provisions, and other considerations in all rate setting packages. We also detail our expectations for states when they submit rate certifications. E:\FR\FM\12MYN1.SGM 12MYN1 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices Section 1903(m) of the Social Security Act requires capitation rates paid to Medicaid managed care organizations (MCOs) to be actuarially sound. Regulations at § 438.4 require all capitation rates paid to an MCO, Prepaid Inpatient Health Plan (PIHP), or Prepaid Ambulatory Health Plans (PAHP) to be actuarially sound and require that each state submit a rate certification for each set of capitation rates developed. Regulations at § 438.7(e) also require that CMS annually publish this guidance; Form Number: CMS–10398 (#37) (OMB control number: 0938–1148); Frequency: Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 46; Total Annual Responses: 135; Total Annual Hours: 608. (For policy questions regarding this collection contact Amy Gentile at 410– 786–3499.) Dated: May 7, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–10050 Filed 5–11–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1609] Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.’’ The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance, which consists of a Guidance and Annexes, provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/ biological products. This guidance khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 finalizes the draft guidance of the same title issued on May 31, 2018. DATES: The announcement of the guidance is published in the Federal Register on May 12, 2021. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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 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– 2018–D–1609 for ‘‘Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.’’ Received comments 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 26043 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.’’ The Agency will review this copy, including the claimed confidential information, in its 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-201509-18/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– E:\FR\FM\12MYN1.SGM 12MYN1

Agencies

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26042-26043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10398 #37]


Medicaid and Children's Health Insurance Program (CHIP) Generic 
Information Collection Activities: Proposed Collection; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: On May 28, 2010, the Office of Management and Budget (OMB) 
issued Paperwork Reduction Act (PRA) guidance \1\ related to the 
``generic'' clearance process. Generally, this is an expedited process 
by which agencies may obtain OMB's approval of collection of 
information requests that are ``usually voluntary, low-burden, and 
uncontroversial collections,'' do not raise any substantive or policy 
issues, and do not require policy or methodological review. The process 
requires the submission of an overarching plan that defines the scope 
of the individual collections that would fall under its umbrella. On 
October 23, 2011, OMB approved our initial request to use the generic 
clearance process under control number 0938-1148 (CMS-10398). It was 
last approved on April 26, 2021, via the standard PRA process which 
included the publication of 60- and 30-day Federal Register notices. 
The scope of the April 2021 umbrella accounts for Medicaid and CHIP 
State plan amendments, waivers, demonstrations, and reporting. This 
Federal Register notice seeks public comment on one or more of our 
collection of information requests that we believe are generic and fall 
within the scope of the umbrella. Interested persons are invited to 
submit comments regarding our burden estimates 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.
---------------------------------------------------------------------------

    \1\ https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_ICRs_5-28-2010.pdf.

---------------------------------------------------------------------------
DATES: Comments must be received by May 26, 2021.

ADDRESSES: When commenting, please reference the applicable form number 
(see below) and the OMB control number (0938-1148). To be assured 
consideration, comments and recommendations must be submitted in any 
one of the following ways:
    1. Electronically. You may send your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: CMS-10398 (#37)/OMB 
control number: 0938-1148, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may 
access CMS' website at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Following is a summary of the use and burden 
associated with the subject information collection(s). More detailed 
information can be found in the collection's supporting statement and 
associated materials (see ADDRESSES).

Generic Information Collection

    1. Title of Information Collection: Medicaid Managed Care Rate 
Development Guide; Type of Information Collection Request: Revision of 
a currently approved collection; Use: States are required to submit 
rate certifications for all Medicaid managed care capitation rates per 
42 CFR 438.7. Our collection of information request specifies our 
requirements for the rate certification and details what types of 
documentation we expect to be included. Elements include descriptions 
of data used, projected benefit and non-benefit costs, rate range 
development, risk and contract provisions, and other considerations in 
all rate setting packages. We also detail our expectations for states 
when they submit rate certifications.

[[Page 26043]]

    Section 1903(m) of the Social Security Act requires capitation 
rates paid to Medicaid managed care organizations (MCOs) to be 
actuarially sound. Regulations at Sec.  438.4 require all capitation 
rates paid to an MCO, Prepaid Inpatient Health Plan (PIHP), or Prepaid 
Ambulatory Health Plans (PAHP) to be actuarially sound and require that 
each state submit a rate certification for each set of capitation rates 
developed. Regulations at Sec.  438.7(e) also require that CMS annually 
publish this guidance; Form Number: CMS-10398 (#37) (OMB control 
number: 0938-1148); Frequency: Occasionally; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 46; Total Annual 
Responses: 135; Total Annual Hours: 608. (For policy questions 
regarding this collection contact Amy Gentile at 410-786-3499.)

    Dated: May 7, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-10050 Filed 5-11-21; 8:45 am]
BILLING CODE 4120-01-P
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