Agency Information Collection Activities: Proposed Collection; Comment Request, 44610-44611 [2016-16220]

Download as PDF 44610 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices Point Bank and Trust Company, High Point, North Carolina. which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action. * * * * * Board of Governors of the Federal Reserve System, July 5, 2016. Margaret Shanks, Deputy Secretary of the Board. PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer; Telephone: (202) 694–1220. Shawn Woodhead Werth, Commission Secretary and Clerk. BILLING CODE 6715–01–P Centers for Medicare & Medicaid Services FEDERAL RESERVE SYSTEM asabaliauskas on DSK3SPTVN1PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 4, 2016. A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261–4528. Comments can also be sent electronically to Comments.applications@rich.frb.org: 1. BNC Bancorp, High Point, North Carolina; to acquire 100 percent of the voting shares of High Point Bank Corporation, High Point, North Carolina, and thereby indirectly acquire High 17:00 Jul 07, 2016 Jkt 238001 BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–16268 Filed 7–6–16; 11:15 am] VerDate Sep<11>2014 [FR Doc. 2016–16255 Filed 7–7–16; 8:45 am] [Document Identifiers: CMS–10137, CMS– 10237 and CMS–379] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by September 6, 2016. 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 http:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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 ll, 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’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995. 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: Reports Clearance Office at (410) 786– 1326. 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–10137 Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts CMS–10237 Applications for Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide Part C Benefits CMS–379 Financial Statement of Debtor 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 E:\FR\FM\08JYN1.SGM 08JYN1 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts; Use: Coverage for the prescription drug benefit is provided through contracted prescription drug (PD) plans or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA–PD plans). Cost Plans that are regulated under section 1876 of the Social Security Act, and Employer Group Waiver Plans may also provide a part D benefit. Organizations wishing to provide services under the Prescription Drug Benefit Program must complete an application, negotiate rates, and receive final approval from CMS. Existing part D Sponsors may also expand their contracted service area by completing the Service Area Expansion application. Form Number: CMS–10137 (OMB control number: 0938–0936); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Notfor-profit institutions); Number of Respondents: 463; Total Annual Responses: 160; Total Annual Hours: 1,565. (For policy questions regarding this collection contact Arianne Spaccarelli at 410–786–5715.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Applications for part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide part C Benefits; Use: This information collection includes the process for organizations wishing to provide healthcare services under MA and/or MA–PD plans must complete an application annually, file a bid, and receive final approval from CMS. The application process has two options for applicants that include: Request for new MA product or request for expanding the service area of an existing product. This collection process is the only mechanism for MA and/or MA–PD organizations to complete the required application process. CMS utilizes the application process as the means to review, assess and determine if applicants are compliant with the current requirements for participation in the Medicare Advantage program and to make a decision related to contract award. Form Number: CMS–10237 (OMB control number: 0938–0935); Frequency: Yearly; Affected Public: Private sector (Business or other For- VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 profits and Not-for-profit institutions); Number of Respondents: 310; Total Annual Responses: 310; Total Annual Hours: 10,941. (For policy questions regarding this collection contact Marcella Watts at 410–786–5724.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Financial Statement of Debtor; Use: Section 1893(f)(1)) of the Social Security Act and 42 CFR 401.607 provides the authority for collection of this information. Section 42 CFR 405.607 requires that, CMS recover amounts of claims due from debtors including interest where appropriate by direct collections in lump sums or in installments. In addition, the DOJ Final Rule, the Federal Claims Collection Standards, which was published as 32 CFR parts 900–904, on November 22, 2000, in the Federal Register, section 32 CFR 900.1 stipulates that, standards for Federal agency use in the administrative collection, offset, compromise, and the suspension or termination of collection activity. Section 32 CFR 901.8(a) states that, Agencies should obtain financial statements from debtors who represent that they are unable to pay the debt in one lump sum. Form Number: CMS–379 (OMB control number: 0938–0270); Frequency: Yearly; Affected Public: Private sector (Business or other forprofits); Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 1,000. (For policy questions regarding this collection contact Anita Crosier at 410–786–0217.) Dated: July 5, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016–16220 Filed 7–7–16; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1233] Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 44611 announcing the availability of the draft guidance entitled ‘‘Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.’’ This draft guidance document describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA’s regulatory review of next generation sequencing (NGS)based tests. This draft guidance further outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. This draft guidance is not final nor is it in effect at this time. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 6, 2016. DATES: ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://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’’). E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44610-44611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10137, CMS-10237 and CMS-379]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by September 6, 2016.

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 
http://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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: Reports Clearance Office at (410) 786-
1326.

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-10137 Solicitation for Applications for Medicare Prescription Drug 
Plan 2018 Contracts
CMS-10237 Applications for Part C Medicare Advantage, 1876 Cost Plans, 
and Employer Group Waiver Plans to Provide Part C Benefits
CMS-379 Financial Statement of Debtor

    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

[[Page 44611]]

requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2018 Contracts; Use: 
Coverage for the prescription drug benefit is provided through 
contracted prescription drug (PD) plans or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under section 
1876 of the Social Security Act, and Employer Group Waiver Plans may 
also provide a part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion application. Form Number: CMS-
10137 (OMB control number: 0938-0936); Frequency: Yearly; Affected 
Public: Private sector (Business or other For-profits and Not-for-
profit institutions); Number of Respondents: 463; Total Annual 
Responses: 160; Total Annual Hours: 1,565. (For policy questions 
regarding this collection contact Arianne Spaccarelli at 410-786-5715.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Applications for 
part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver 
Plans to Provide part C Benefits; Use: This information collection 
includes the process for organizations wishing to provide healthcare 
services under MA and/or MA-PD plans must complete an application 
annually, file a bid, and receive final approval from CMS. The 
application process has two options for applicants that include: 
Request for new MA product or request for expanding the service area of 
an existing product. This collection process is the only mechanism for 
MA and/or MA-PD organizations to complete the required application 
process. CMS utilizes the application process as the means to review, 
assess and determine if applicants are compliant with the current 
requirements for participation in the Medicare Advantage program and to 
make a decision related to contract award. Form Number: CMS-10237 (OMB 
control number: 0938-0935); Frequency: Yearly; Affected Public: Private 
sector (Business or other For-profits and Not-for-profit institutions); 
Number of Respondents: 310; Total Annual Responses: 310; Total Annual 
Hours: 10,941. (For policy questions regarding this collection contact 
Marcella Watts at 410-786-5724.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Financial 
Statement of Debtor; Use: Section 1893(f)(1)) of the Social Security 
Act and 42 CFR 401.607 provides the authority for collection of this 
information. Section 42 CFR 405.607 requires that, CMS recover amounts 
of claims due from debtors including interest where appropriate by 
direct collections in lump sums or in installments. In addition, the 
DOJ Final Rule, the Federal Claims Collection Standards, which was 
published as 32 CFR parts 900-904, on November 22, 2000, in the Federal 
Register, section 32 CFR 900.1 stipulates that, standards for Federal 
agency use in the administrative collection, offset, compromise, and 
the suspension or termination of collection activity. Section 32 CFR 
901.8(a) states that, Agencies should obtain financial statements from 
debtors who represent that they are unable to pay the debt in one lump 
sum. Form Number: CMS-379 (OMB control number: 0938-0270); Frequency: 
Yearly; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 500; Total Annual Responses: 500; 
Total Annual Hours: 1,000. (For policy questions regarding this 
collection contact Anita Crosier at 410-786-0217.)

    Dated: July 5, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-16220 Filed 7-7-16; 8:45 am]
 BILLING CODE 4120-01-P