81 FR 81148 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 222 (November 17, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 222 (November 17, 2016)
| Page Range | 81148-81149 | |
| FR Document | 2016-27550 |
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)] [Notices] [Pages 81148-81149] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27550] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10069] 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 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 January 17, 2017. 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 [email protected]. 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-10069 Medicare/Medicaid Demonstration/Model Application 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 [[Page 81149]] 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: Extension of a currently approved collection; Title of Information Collection: Medicare/Medicaid Demonstration/Model Application; Use: The application is used for solicitation of proposals that are either congressionally mandated or Administration high priority demonstration initiatives which would be used to strengthen and modernize the Medicare and/or Medicaid programs. The standardized proposal format is not controversial and will reduce burden on applicants and reviewers. Responses are strictly voluntary. The standard format will enable CMS to select proposals that meet CMS objectives and show the best potential for success. Form Number: CMS- 10069 (OMB control number: 0938-0880); Frequency: Once; Affected Public: Private sector--Business or other for-profits and Not-for- profit institutions; Number of Respondents: 75; Total Annual Responses: 75; Total Annual Hours: 6,000. (For policy questions regarding this collection contact John Amoh at 410-786-4910). Dated: November 10, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-27550 Filed 11-16-16; 8:45 am] BILLING CODE 4120-01-P
![81148 Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
published a Paperwork Reduction Act We are now seeking approval to automated collection techniques or
notice requesting a 60-day public update our burden estimates to all other forms of information technology to
comment period for the information Forms to account for the consolidation minimize the information collection
collection request identified under of all rounds in Round 2019. For Round burden.
CMS–10169, OMB control number 2019 and the proposed rule, CMS will DATES: Comments must be received by
0938–1016, and titled ‘‘Durable Medical publish a slightly modified version of
January 17, 2017.
Equipment, Prosthetics, Orthotics, and Form A so that suppliers will be better
able to identify and understand the new ADDRESSES: When commenting, please
Supplies (DMEPOS) Competitive
Bidding Program; Change of Ownership requirement related to surety bonds. We reference the document identifier or
Forms.’’ have made no changes to Forms B, C, D, OMB control number. To be assured
Change of Ownership (CHOW) Contract consideration, comments and
II. Explanation of Error Supplier Notification and Purchaser recommendations must be submitted in
In the October 14, 2016, notice, the Forms, and Subcontracting Disclosure any one of the following ways:
information provided in the first Form. However, the burden has been 1. Electronically. You may send your
column under paragraph 2, on page adjusted to account for the increase in comments electronically to http://
71101, inadvertently published the number of respondents due to the www.regulations.gov. Follow the
information in the ‘‘Use’’ section that consolidation of all CBAs into Round instructions for ‘‘Comment or
pertained to an older iteration of the 2019 under this ICR. We intend to Submission’’ or ‘‘More Search Options’’
information collection request. This continue use of these Forms on an to find the information collection
notice corrects the language found in ongoing basis. document(s) that are accepting
the ‘‘Use’’ section under the 2nd comments.
Dated: November 10, 2016.
paragraph on page 71101 of the October 2. By regular mail. You may mail
William N. Parham, III,
14th notice. All of the other information written comments to the following
Director, Paperwork Reduction Staff, Office address: CMS, Office of Strategic
contained in the October 14, 2016, of Strategic Operations and Regulatory
notice is correct. The related public Affairs.
Operations and Regulatory Affairs,
comment period remains in effect and Division of Regulations Development,
[FR Doc. 2016–27549 Filed 11–16–16; 8:45 am]
ends December 13, 2016. Attention: Document Identifier/OMB
BILLING CODE 4120–01–P
Control Numberll, Room C4–26–05,
III. Correction of Error 7500 Security Boulevard, Baltimore,
In FR Doc. 2016–24910 of October 14, DEPARTMENT OF HEALTH AND Maryland 21244–1850.
2016 (81 FR 71100), on page 71101, the HUMAN SERVICES To obtain copies of a supporting
language beginning with the word statement and any related forms for the
‘‘Use:’’ in the first column, in the first Centers for Medicare & Medicaid proposed collection(s) summarized in
full paragraph, in the 8th line, and Services this notice, you may make your request
ending in the second column, with the [Document Identifier CMS–10069]
using one of following:
word ‘‘basis’’, in the second column, in 1. Access CMS’ Web site address at
the 33rd line, is corrected to read as Agency Information Collection http://www.cms.hhs.gov/
follows: Activities: Proposed Collection; PaperworkReductionActof1995.
Use: The MMA requires the Secretary Comment Request 2. Email your request, including your
to recompete contracts not less often address, phone number, OMB number,
AGENCY: Centers for Medicare & and CMS document identifier, to
than once every 3 years. Section Medicaid Services, HHS.
1847(a)(1)(G) of the Act, added by Paperwork@cms.hhs.gov.
ACTION: Notice. 3. Call the Reports Clearance Office at
section 522(a) of the MACRA, now
requires a bid surety bond for bidding SUMMARY: The Centers for Medicare & (410) 786–1326.
entities beginning not earlier than Medicaid Services (CMS) is announcing FOR FURTHER INFORMATION CONTACT:
January 1, 2017 and not later than an opportunity for the public to Reports Clearance Office at (410) 786–
January 1, 2019. The addition to the Act comment on CMS’ intention to collect 1326.
states that a bidding entity may not information from the public. Under the SUPPLEMENTARY INFORMATION:
submit a bid for a CBA unless, as of the Paperwork Reduction Act of 1995 (the
deadline for bid submission, the entity PRA), federal agencies are required to Contents
has (1) obtained a bid surety bond, in publish notice in the Federal Register This notice sets out a summary of the
the range of $50,000 to $100,000 and (2) concerning each proposed collection of use and burden associated with the
provided the Secretary with proof of information (including each proposed following information collections. More
having obtained the bid surety bond for extension or reinstatement of an existing detailed information can be found in
each CBA in which the entity submits collection of information) and to allow each collection’s supporting statement
its bid(s). 60 days for public comment on the and associated materials (see
Based on the passage of MACRA, we proposed action. Interested persons are ADDRESSES).
put forth proposed additions to invited to send comments regarding our
§ 414.412, ‘‘Submission of bids under a burden estimates or any other aspect of CMS–10069 Medicare/Medicaid
competitive bidding program,’’ to add a this collection of information, including Demonstration/Model Application
asabaliauskas on DSK3SPTVN1PROD with NOTICES
new paragraph (h) that would allow any of the following subjects: (1) The Under the PRA (44 U.S.C. 3501–
CMS to implement section 1847(a)(1)(G) necessity and utility of the proposed 3520), federal agencies must obtain
of the Act, as amended by section 522(a) information collection for the proper approval from the Office of Management
of MACRA, to state that an entity may performance of the agency’s functions; and Budget (OMB) for each collection of
not submit a bid for a CBA unless, as of (2) the accuracy of the estimated information they conduct or sponsor.
the deadline for bid submission, the burden; (3) ways to enhance the quality, The term ‘‘collection of information’’ is
entity has obtained a bid surety bond for utility, and clarity of the information to defined in 44 U.S.C. 3502(3) and 5 CFR
the CBA. be collected; and (4) the use of 1320.3(c) and includes agency requests
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![Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices 81149
or requirements that members of the expeditious commercialization of Application No. 62/014,814; PCT/
public submit reports, keep records, or results of federally-funded research and US2015/029843.
provide information to a third party. development. Foreign patent Licensing Contact: Dr. Jenish Patel,
Section 3506(c)(2)(A) of the PRA applications are filed on selected (240) 669–2894, jenish.patel@nih.gov.
requires federal agencies to publish a inventions to extend market coverage Collaborative Research Opportunity:
60-day notice in the Federal Register for companies and may also be available The National Institute of Allergy and
concerning each proposed collection of for licensing. Infectious Diseases is seeking statements
information, including each proposed FOR FURTHER INFORMATION CONTACT:
of capability or interest from parties
extension or reinstatement of an existing Licensing information may be obtained interested in collaborative research to
collection of information, before by communicating with the indicated further develop, evaluate or
submitting the collection to OMB for licensing contact at the Technology commercialize this invention, especially
approval. To comply with this Transfer and Intellectual Property for GMP manufacture and clinical
requirement, CMS is publishing this Office, National Institute of Allergy and evaluation. For collaboration
notice. Infectious Diseases, 5601 Fishers Lane, opportunities, please contact Dr. Jenish
Rockville, MD 20852; tel. 301–496– Patel, (240) 669–2894, jenish.patel@
Information Collection nih.gov.
2644. A signed Confidential Disclosure
1. Type of Information Collection Agreement will be required to receive Dated: November 14, 2016.
Request: Extension of a currently copies of unpublished scientific data. Suzanne Frisbie,
approved collection; Title of Deputy Director, Technology Transfer and
SUPPLEMENTARY INFORMATION:
Information Collection: Medicare/ Intellectual Property Office, National Institute
Technology description follows.
Medicaid Demonstration/Model of Allergy and Infectious Diseases.
Application; Use: The application is Polyvalent Influenza Virus-Like [FR Doc. 2016–27676 Filed 11–16–16; 8:45 am]
used for solicitation of proposals that Particles (VLPs) and Use as Vaccines BILLING CODE 4140–01–P
are either congressionally mandated or Description of Technology: This virus-
Administration high priority like particle (VLP) vaccine technology
demonstration initiatives which would for influenza viruses, based on a DEPARTMENT OF HEALTH AND
be used to strengthen and modernize the mixture of VLPs expressing the HUMAN SERVICES
Medicare and/or Medicaid programs. hemagglutinin protein or the
The standardized proposal format is not National Institutes of Health
neuraminidase protein from influenza
controversial and will reduce burden on virus strains belonging to different virus
applicants and reviewers. Responses are National Institute of Allergy and
subtypes, has demonstrated broad Infectious Diseases; Notice of Closed
strictly voluntary. The standard format protection against lethal challenge in
will enable CMS to select proposals that Meetings
mice with various influenza virus
meet CMS objectives and show the best strains and virus subtypes. Results from Pursuant to section 10(d) of the
potential for success. Form Number: ferret and mouse studies demonstrate Federal Advisory Committee Act, as
CMS–10069 (OMB control number: broad heterosubtypic protection against amended (5 U.S.C. App.), notice is
0938–0880); Frequency: Once; Affected various influenza virus subtypes further hereby given of the following meetings.
Public: Private sector—Business or other supporting and strengthening the The meetings will be closed to the
for-profits and Not-for-profit proposed application of this technology public in accordance with the
institutions; Number of Respondents: as a universal influenza virus vaccine. provisions set forth in sections
75; Total Annual Responses: 75; Total This technology is available for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Annual Hours: 6,000. (For policy licensing for commercial development as amended. The grant applications and
questions regarding this collection in accordance with 35 U.S.C. 209 and 37 the discussions could disclose
contact John Amoh at 410–786–4910). CFR part 404, as well as for further confidential trade secrets or commercial
Dated: November 10, 2016. development and evaluation under a property such as patentable material,
William N. Parham, III, research collaboration. and personal information concerning
Director, Paperwork Reduction Staff, Office Potential Commercial Applications: individuals associated with the grant
of Strategic Operations and Regulatory • Vaccines applications, the disclosure of which
Affairs. Competitive Advantages: would constitute a clearly unwarranted
[FR Doc. 2016–27550 Filed 11–16–16; 8:45 am] • Broad/universal protection against invasion of personal privacy.
BILLING CODE 4120–01–P influenza viruses Name of Committee: National Institute of
• does not require reformulating Allergy and Infectious Diseases Special
vaccine each year as is currently Emphasis Panel; ‘‘Advancing HIV
DEPARTMENT OF HEALTH AND necessary with vaccines available on the Therapeutic Vaccine Science (U01)’’.
Date: December 12, 2016.
HUMAN SERVICES market
Time: 10:00 a.m. to 4:00 p.m.
• can potentially provide protection Agenda: To review and evaluate grant
National Institutes of Health against novel influenza viruses that may applications.
arise in the future, including potentially Place: National Institutes of Health, 5601
Government-Owned Invention; pandemic influenza viruses Fishers Lane, Rockville, MD 20892
Availability for Licensing Inventors: Dr. Jeffery Taubenberger of (Telephone Conference Call).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: National Institutes of Health, NIAID. Contact Person: Jay R. Radke, Ph.D., AIDS
Publications: Schwartzman, et al. An Review Branch, Scientific Review Program,
HHS. Division of Extramural Activities, Room
ACTION: Notice. Intranasal Virus-Like Particle Vaccine #3G11B, National Institutes of Health, NIAID,
Broadly Protects Mice from Multiple 5601 Fishers Lane MSC–9823, Bethesda, MD
SUMMARY: The invention listed below is Subtypes of Influenza A Virus. 2015. 20892–9823, (240) 669–5046, jay.radke@
owned by an agency of the U.S. MBio. 6(4): e01044–15. nih.gov.
Government and is available for Intellectual Property: HHS Reference Name of Committee: National Institute of
licensing in the U.S. to achieve No. E–195–2014, U.S. Provisional Allergy and Infectious Diseases Special
VerDate Sep<11>2014 21:24 Nov 16, 2016 Jkt 241001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\17NON1.SGM 17NON1](https://thefederalregister.org/doc/81_FR_81370/page/2.svg)
Document Created: 2016-11-17 03:00:28
Document Modified: 2016-11-17 03:00:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by January 17, 2017. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 81148 |
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