Agency Information Collection Activities: Proposed Collection; Comment Request, 57876-57877 [2019-23572]

Download as PDF 57876 Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10631] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send 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. DATES: Comments must be received by December 30, 2019. ADDRESSES: When commenting, please reference the document identifier or OMB control number. 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: Document Identifier/OMB Control Number llll , Room C4– 26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the SUMMARY: VerDate Sep<11>2014 17:05 Oct 28, 2019 Jkt 250001 proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ website address at https://www.cms.gov/Regulations-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing.html 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10631 The PACE Organization Application Process in 42 CFR Part 460 Under the 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 requires federal agencies to publish a 60-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. Information Collection 1. Type of Information Collection Request: Revision with change of a currently approved collection; Title of Information Collection: The PACE Organization Application Process in 42 CFR part 460; Use: The Programs of AllInclusive Care for the Elderly (PACE) consist of pre-paid, capitated plans that provide comprehensive health care services to frail, older adults in the community who are eligible for nursing home care according to State standards. PACE organizations (PO) must provide all Medicare and Medicaid covered services; financing of this model is accomplished through prospective PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 capitation of both Medicare and Medicaid payments. Upon approval of a PACE application, CMS executes a 3way program agreement with the applicant entity and the applicable State Administering Agency (SAA). CMS regulations at 42 CFR 460.98(b)(2) require a PO to provide PACE services in at least the PACE center, the home, and inpatient facilities. The PACE center is the focal point for the delivery of PACE services; the center is where the interdisciplinary team (IDT) is located, services are provided, and socialization occurs with staff that is consistent and familiar to participants. Collection of this information is mandated by statute under sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart B, which addresses the PO application and waiver process. In general, PACE services are provided through a PO. An entity wishing to become a PO must submit an application to CMS that describes how the entity meets all the requirements in the PACE program. An entity’s application must be accompanied by an assurance from the SAA of the State in which the PO is located. CMS recently issued a final PACE rule (CMS–4168–F), effective August 2, 2019, which updates and modernizes the PACE program. This final rule codifies CMS’ existing practice of relying on automated review systems for processing initial applications to become a PACE organization and expansion applications for existing PACE organizations. In addition, the final rule will modify the PACE regulations to eliminate the need for PACE organizations to request waivers for a number of the most commonly waived provisions. This latter change is expected to reduce burden and improve efficiency for POs, state administering agencies, and CMS. In addition to codifying the current automated processes for the submission and review of both initial and service area expansion applications, this rule modifies existing regulatory provisions and requirements. As a result, certain attestations associated with the application are no longer applicable, and others need to be updated to reflect updated regulatory requirements. We are also making minor tweaks to certain document upload requirements for clarification purposes based on experience reviewing applications. Form Number: CMS–10631 (OMB control number: 0938–1326); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 72; Total Annual Responses: 109; Total Annual Hours: E:\FR\FM\29OCN1.SGM 29OCN1 Federal Register / Vol. 84, No. 209 / Tuesday, October 29, 2019 / Notices 7,226. (For policy questions regarding this collection contact Debbie Vanhoven at 410–786–6625.) Dated: October 24, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–23572 Filed 10–28–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4258] Type V Drug Master Files for Center for Drug Evaluation and Research-Led Combination Products Using Device Constituent Parts With Electronics or Software; Draft 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 draft guidance for industry entitled ‘‘Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.’’ A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. This draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., a CDER-led combination product) and which features a device constituent part with electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products. The draft guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments. DATES: Submit either electronic or written comments on the draft guidance by December 30, 2019 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: SUMMARY: VerDate Sep<11>2014 17:05 Oct 28, 2019 Jkt 250001 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– 2019–D–4258 for ‘‘Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.’’ 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 a.m. and 4 p.m., Monday through Friday. • 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 57877 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Kimberly Peters, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 4314, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796– 6350. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Type V DMFs for CDER-Led Combination Products Using Device E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Pages 57876-57877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23572]



[[Page 57876]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10631]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
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.

DATES: Comments must be received by December 30, 2019.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. 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: Document Identifier/OMB 
Control Number ____ , 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 make 
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10631 The PACE Organization Application Process in 42 CFR Part 460

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: The 
PACE Organization Application Process in 42 CFR part 460; Use: The 
Programs of All-Inclusive Care for the Elderly (PACE) consist of pre-
paid, capitated plans that provide comprehensive health care services 
to frail, older adults in the community who are eligible for nursing 
home care according to State standards. PACE organizations (PO) must 
provide all Medicare and Medicaid covered services; financing of this 
model is accomplished through prospective capitation of both Medicare 
and Medicaid payments. Upon approval of a PACE application, CMS 
executes a 3-way program agreement with the applicant entity and the 
applicable State Administering Agency (SAA). CMS regulations at 42 CFR 
460.98(b)(2) require a PO to provide PACE services in at least the PACE 
center, the home, and inpatient facilities. The PACE center is the 
focal point for the delivery of PACE services; the center is where the 
interdisciplinary team (IDT) is located, services are provided, and 
socialization occurs with staff that is consistent and familiar to 
participants.
    Collection of this information is mandated by statute under 
sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart 
B, which addresses the PO application and waiver process. In general, 
PACE services are provided through a PO. An entity wishing to become a 
PO must submit an application to CMS that describes how the entity 
meets all the requirements in the PACE program. An entity's application 
must be accompanied by an assurance from the SAA of the State in which 
the PO is located.
    CMS recently issued a final PACE rule (CMS-4168-F), effective 
August 2, 2019, which updates and modernizes the PACE program. This 
final rule codifies CMS' existing practice of relying on automated 
review systems for processing initial applications to become a PACE 
organization and expansion applications for existing PACE 
organizations. In addition, the final rule will modify the PACE 
regulations to eliminate the need for PACE organizations to request 
waivers for a number of the most commonly waived provisions. This 
latter change is expected to reduce burden and improve efficiency for 
POs, state administering agencies, and CMS.
    In addition to codifying the current automated processes for the 
submission and review of both initial and service area expansion 
applications, this rule modifies existing regulatory provisions and 
requirements. As a result, certain attestations associated with the 
application are no longer applicable, and others need to be updated to 
reflect updated regulatory requirements. We are also making minor 
tweaks to certain document upload requirements for clarification 
purposes based on experience reviewing applications. Form Number: CMS-
10631 (OMB control number: 0938-1326); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 72; 
Total Annual Responses: 109; Total Annual Hours:

[[Page 57877]]

7,226. (For policy questions regarding this collection contact Debbie 
Vanhoven at 410-786-6625.)

    Dated: October 24, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-23572 Filed 10-28-19; 8:45 am]
 BILLING CODE 4120-01-P


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