Agency Information Collection Activities: Proposed Collection; Comment Request, 4993-4994 [2020-01463]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices 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: Revision of a currently approved collection; Title of Information Collection: Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report; Use: The collected baseline data is used to assess the effectiveness of state early and periodic screening, diagnostic and treatment (EPSDT) programs in reaching eligible children (by age group and basis of Medicaid eligibility) who are provided initial and periodic child health screening services, referred for corrective treatment, and receiving dental, hearing, and vision services. This assessment is coupled with the state’s results in attaining the participation goals set for the state. The information gathered from this report, permits federal and state managers to evaluate the effectiveness of the EPSDT law on the basic aspects of the program. Form Number: CMS–416 (OMB control number 0938–0354); Frequency: Yearly and on occasion; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,512. (For policy questions regarding this collection contact Karen Matsuoka at 410–786–9726.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: PACE State Plan Amendment Preprint; Use: If a state elects to offer PACE as an optional Medicaid benefit, it must complete a state plan amendment preprint packet described as ‘‘Enclosures 3, 4, 5, 6, and 7.’’ CMS will review the information provided in order to determine if the state has properly elected to cover PACE services as a state plan option. In the event that the state changes something in the state plan, only the affected page must be updated. Form Number: CMS– 10227 (OMB control number: 0938– 1027); Frequency: Once and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 7; Total Annual Responses: 2; Total Annual Hours: 140. (For policy questions regarding this collection contact Angela Cimino at 410–786–2638.) VerDate Sep<11>2014 17:02 Jan 27, 2020 Jkt 250001 Dated: January 22, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–01348 Filed 1–27–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10725] 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 March 30, 2020. 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 SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 4993 address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number l, 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 website address at https://www.cms.gov/ Regulations-and-Guidance/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–10725 Pharmacy Benefit Manager Transparency 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: New information collection (Request for a new OMB control number); Title of Information Collection: Pharmacy Benefit Manager Transparency; Use: The Patient Protection and Affordable Care Act E:\FR\FM\28JAN1.SGM 28JAN1 4994 Federal Register / Vol. 85, No. 18 / Tuesday, January 28, 2020 / Notices (Pub. L. 111–148) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) (collectively, the Patient Protection and Affordable Care Act (PPACA)) were signed into law in 2010. The PPACA established competitive private health insurance markets, called Marketplaces or Exchanges, which give millions of Americans and small businesses access to qualified health plans (QHPs), including stand-alone dental plans (SADPs)—private health and dental insurance plans that are certified as meeting certain standards. The PPACA added section 1150A of the Social Security Act, which requires pharmacy benefit managers (PBMs) to report prescription benefit information to the Department of Health and Human Services (HHS). PBMs are third-party administrators of prescription programs for a variety of types of health plans, including QHPs. The Centers for Medicare and Medicaid Services (CMS) files this information collection request (ICR) in connection with the prescription benefit information that PBMs must provide to HHS under section 1150A. The burden estimate for this ICR reflects the time and effort for PBMs to submit the information regarding PBMs and prescription drugs. Form Number: CMS–10725 (OMB control number: 0938–NEW); Frequency: Annually; Affected Public: Private Sector (business or other forprofits), Number of Respondents: 40; Number of Responses: 275. Total Annual Hours: 1,400. For questions regarding this collection contact Ken Buerger at 410–786–1190. Dated: January 23, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–01463 Filed 1–27–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jbell on DSKJLSW7X2PROD with NOTICES [Docket No. FDA–2019–N–5900] Agency Information Collection Activities; Proposed Collection; Comment Request; Endorser Status and Explicitness of Payment in Directto-Consumer Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is 17:02 Jan 27, 2020 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 SUMMARY: VerDate Sep<11>2014 announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ‘‘Endorser Status and Explicitness of Payment in Direct-toConsumer Promotion.’’ DATES: Submit either electronic or written comments on the collection of information by March 30, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 30, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Jkt 250001 Submit written/paper submissions as follows: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 • 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–N–5900 for ‘‘Endorser Status and Explicitness of Payment in Direct-toConsumer Promotion.’’ 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. • 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 E:\FR\FM\28JAN1.SGM 28JAN1

Agencies

[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4993-4994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10725]


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 March 30, 2020.

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 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-10725 Pharmacy Benefit Manager Transparency

    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: New information 
collection (Request for a new OMB control number); Title of Information 
Collection: Pharmacy Benefit Manager Transparency; Use: The Patient 
Protection and Affordable Care Act

[[Page 4994]]

(Pub. L. 111-148) and the Health Care and Education Reconciliation Act 
of 2010 (Pub. L. 111-152) (collectively, the Patient Protection and 
Affordable Care Act (PPACA)) were signed into law in 2010. The PPACA 
established competitive private health insurance markets, called 
Marketplaces or Exchanges, which give millions of Americans and small 
businesses access to qualified health plans (QHPs), including stand-
alone dental plans (SADPs)--private health and dental insurance plans 
that are certified as meeting certain standards. The PPACA added 
section 1150A of the Social Security Act, which requires pharmacy 
benefit managers (PBMs) to report prescription benefit information to 
the Department of Health and Human Services (HHS). PBMs are third-party 
administrators of prescription programs for a variety of types of 
health plans, including QHPs. The Centers for Medicare and Medicaid 
Services (CMS) files this information collection request (ICR) in 
connection with the prescription benefit information that PBMs must 
provide to HHS under section 1150A. The burden estimate for this ICR 
reflects the time and effort for PBMs to submit the information 
regarding PBMs and prescription drugs. Form Number: CMS-10725 (OMB 
control number: 0938-NEW); Frequency: Annually; Affected Public: 
Private Sector (business or other for-profits), Number of Respondents: 
40; Number of Responses: 275. Total Annual Hours: 1,400. For questions 
regarding this collection contact Ken Buerger at 410-786-1190.

    Dated: January 23, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-01463 Filed 1-27-20; 8:45 am]
BILLING CODE 4120-01-P

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