81 FR 49984 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 146 (July 29, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 146 (July 29, 2016)
| Page Range | 49984-49985 | |
| FR Document | 2016-17988 |
[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)] [Notices] [Pages 49984-49985] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17988] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10053, CMS-10302 and CMS-10468] Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by August 29, 2016. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR Email: [email protected]. 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: Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Paid Feeding Assistants in Long-Term Care Facilities and Supporting Regulations; Use: In accordance with 42 CFR part 483, long-term care facilities are permitted to use paid feeding assistants to supplement the services of certified nurse aides. If facilities choose this option, feeding assistants must complete a training program. Nursing home providers are expected to maintain a record of all individuals used by the facility as paid feeding assistants. Form Number: CMS-10053 (OMB control number: 0938-0916); Frequency: Occasionally; Affected Public: Private Sector-- Business or other for-profit and not-for-profit institutions; Number of Respondents: 4,250; Total Annual Responses: 4,250; Total Annual Hours: 25,500. (For policy questions regarding this collection contact Karen Tritz at 410-786-8021.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti- cancer Chemotherapeutic Regimen Use: Section 182(b) of the Medicare Improvement of Patients and Providers Act (MIPPA) amended section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the following new sentence: `On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interest.' We believe that the implementation of this statutory provision that compendia have a ``publicly transparent process for evaluating therapies and for identifying potential conflicts of interests'' is best accomplished by amending 42 CFR 414.930 to include the MIPPA requirements and by defining the key components of publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests. All currently listed compendia will be required to comply with these provisions, as of January 1, 2010, to remain on the list of recognized compendia. In addition, any compendium that is the subject of a [[Page 49985]] future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. Form Number: CMS-10302 (OMB control number: 0938-1078); Frequency: Annually; Affected Public: Business and other for-profits and Not-for- profit institutions; Number of Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 5,135. (For policy questions regarding this collection contact Cheryl Gilbreath at 410-786-5919.) 3. Type of Information Collection Request: Extension of a previously approved collection; Title of Information Collection: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment; Use: The Patient Protection and Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, expands access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Insurance Exchanges (Exchanges), including the Small Business Health Options Program (SHOP). The Exchanges, which became operational on January 1, 2014, enhanced competition in the health insurance market, expanded access to affordable health insurance for millions of Americans, and provided consumers with a place to easily compare and shop for health insurance coverage. The reporting requirements and data collection in Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment (CMS-2334-F) address: (1) Standards related to notices, (2) procedures for the verification of enrollment in an eligible employer- sponsored plan and eligibility for qualifying coverage in an eligible employer-sponsored plan; and (3) other eligibility and enrollment provisions to provide detail necessary for state implementation. Form Number: CMS-10468 (OMB control number: 0938-1207); Frequency: Annually; Affected Public: Individuals, Households and Private Sector; Number of Respondents: 13,200; Total Annual Responses: 13,200; Total Annual Hours: 8,899. (For policy questions regarding this collection contact Sarah Boehm at 301-492-4429.) Dated: July 26, 2016. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-17988 Filed 7-28-16; 8:45 am] BILLING CODE 4120-01-P
![49984 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices
Nature and Extent of Confidentiality: other aspect of this collection of publishing this notice that summarizes
There is no need for confidentiality with information, including any of the the following proposed collection(s) of
this collection of information. following subjects: (1) The necessity and information for public comment:
Needs and Uses: Section 87.103 states utility of the proposed information 1. Type of Information Collection
the following: (a) Stations at fixed collection for the proper performance of Request: Extension of a currently
locations. The license or a photocopy the agency’s functions; (2) the accuracy approved collection; Title of
must be posted or retained in the of the estimated burden; (3) ways to Information Collection: Paid Feeding
station’s permanent records. (b) Aircraft enhance the quality, utility, and clarity Assistants in Long-Term Care Facilities
radio stations. The license must be of the information to be collected; and and Supporting Regulations; Use: In
either posted in the aircraft or kept with (4) the use of automated collection accordance with 42 CFR part 483, long-
the aircraft registration certificate. If a techniques or other forms of information term care facilities are permitted to use
single authorization covers a fleet of technology to minimize the information paid feeding assistants to supplement
aircraft, a copy of the license must be collection burden. the services of certified nurse aides. If
either posted in each aircraft or kept DATES: Comments on the collection(s) of facilities choose this option, feeding
with each aircraft registration certificate. information must be received by the assistants must complete a training
(c) Aeronautical mobile stations. The OMB desk officer by August 29, 2016. program. Nursing home providers are
license must be retained as a permanent ADDRESSES: When commenting on the expected to maintain a record of all
part of the station records. proposed information collections, individuals used by the facility as paid
The recordkeeping requirement please reference the document identifier feeding assistants. Form Number: CMS–
contained in Section 87.103 is necessary or OMB control number. To be assured 10053 (OMB control number: 0938–
to demonstrate that all transmitters in consideration, comments and 0916); Frequency: Occasionally;
the Aviation Service are properly recommendations must be received by Affected Public: Private Sector—
licensed in accordance with the the OMB desk officer via one of the Business or other for-profit and not-for-
requirements of Section 301 of the following transmissions: OMB, Office of profit institutions; Number of
Communications Act of 1934, as Information and Regulatory Affairs, Respondents: 4,250; Total Annual
amended, 47 U.S.C. 301, No. 2020 of the Attention: CMS Desk Officer, Fax Responses: 4,250; Total Annual Hours:
International Radio Regulation, and Number: (202) 395–5806 OR Email: 25,500. (For policy questions regarding
Article 30 of the Convention on OIRA_submission@omb.eop.gov. this collection contact Karen Tritz at
International Civil Aviation. To obtain copies of a supporting 410–786–8021.)
statement and any related forms for the 2. Type of Information Collection
Federal Communications Commission. Request: Extension of a currently
Marlene H. Dortch, proposed collection(s) summarized in
approved collection; Title of
this notice, you may make your request
Secretary, Office of the Secretary. Information Collection: Collection
using one of following:
[FR Doc. 2016–17901 Filed 7–28–16; 8:45 am] 1. Access CMS’ Web site address at Requirements for Compendia for
BILLING CODE 6712–01–P http://www.cms.hhs.gov/ Determination of Medically-accepted
PaperworkReductionActof1995. Indications for Off-label Uses of Drugs
2. Email your request, including your and Biologicals in an Anti-cancer
DEPARTMENT OF HEALTH AND address, phone number, OMB number, Chemotherapeutic Regimen Use:
HUMAN SERVICES and CMS document identifier, to Section 182(b) of the Medicare
Paperwork@cms.hhs.gov. Improvement of Patients and Providers
Centers for Medicare & Medicaid 3. Call the Reports Clearance Office at Act (MIPPA) amended section
Services (410) 786–1326. 1861(t)(2)(B) of the Social Security Act
FOR FURTHER INFORMATION CONTACT:
(42 U.S.C. 1395x(t)(2)(B)) by adding at
[Document Identifier: CMS–10053, CMS–
the end the following new sentence: ‘On
10302 and CMS–10468] Reports Clearance Office at (410) 786–
and after January 1, 2010, no compendia
1326.
Agency Information Collection may be included on the list of
SUPPLEMENTARY INFORMATION: Under the compendia under this subparagraph
Activities: Submission for OMB
Paperwork Reduction Act of 1995 (PRA) unless the compendia has a publicly
Review; Comment Request
(44 U.S.C. 3501–3520), federal agencies transparent process for evaluating
AGENCY: Centers for Medicare & must obtain approval from the Office of therapies and for identifying potential
Medicaid Services, HHS. Management and Budget (OMB) for each conflicts of interest.’ We believe that the
ACTION: Notice. collection of information they conduct implementation of this statutory
or sponsor. The term ‘‘collection of provision that compendia have a
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. ‘‘publicly transparent process for
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and evaluating therapies and for identifying
an opportunity for the public to includes agency requests or potential conflicts of interests’’ is best
comment on CMS’ intention to collect requirements that members of the public accomplished by amending 42 CFR
information from the public. Under the submit reports, keep records, or provide 414.930 to include the MIPPA
Paperwork Reduction Act of 1995 information to a third party. Section requirements and by defining the key
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. components of publicly transparent
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies processes for evaluating therapies and
concerning each proposed collection of to publish a 30-day notice in the for identifying potential conflicts of
ebenthall on DSK5MVXVN1PROD with NOTICES
information, including each proposed Federal Register concerning each interests.
extension or reinstatement of an existing proposed collection of information, All currently listed compendia will be
collection of information, and to allow including each proposed extension or required to comply with these
a second opportunity for public reinstatement of an existing collection provisions, as of January 1, 2010, to
comment on the notice. Interested of information, before submitting the remain on the list of recognized
persons are invited to send comments collection to OMB for approval. To compendia. In addition, any
regarding the burden estimate or any comply with this requirement, CMS is compendium that is the subject of a
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![Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices 49985
future request for inclusion on the list 13,200; Total Annual Hours: 8,899. (For www.regulations.gov. Follow the
of recognized compendia will be policy questions regarding this instructions for ‘‘Comment or
required to comply with these collection contact Sarah Boehm at 301– Submission’’ or ‘‘More Search Options’’
provisions. No compendium can be on 492–4429.) to find the information collection
the list if it does not fully meet the Dated: July 26, 2016. document(s) that are accepting
standard described in section Martique Jones,
comments.
1861(t)(2)(B) of the Act, as revised by 2. By regular mail. You may mail
Director, Regulations Development Group,
section 182(b) of the MIPPA. Form written comments to the following
Office of Strategic Operations and Regulatory
Number: CMS–10302 (OMB control Affairs. address: CMS, Office of Strategic
number: 0938–1078); Frequency: Operations and Regulatory Affairs,
[FR Doc. 2016–17988 Filed 7–28–16; 8:45 am]
Annually; Affected Public: Business and Division of Regulations Development,
BILLING CODE 4120–01–P
other for-profits and Not-for-profit Attention: Document Identifier/OMB
institutions; Number of Respondents: Control Number lll, Room C4–26–
845; Total Annual Responses: 900; Total DEPARTMENT OF HEALTH AND 05, 7500 Security Boulevard, Baltimore,
Annual Hours: 5,135. (For policy HUMAN SERVICES Maryland 21244–1850.
questions regarding this collection To obtain copies of a supporting
contact Cheryl Gilbreath at 410–786– Centers for Medicare & Medicaid statement and any related forms for the
5919.) Services proposed collection(s) summarized in
3. Type of Information Collection this notice, you may make your request
[Document Identifiers: CMS–10311, CMS– using one of following:
Request: Extension of a previously 10242]
approved collection; Title of 1. Access CMS’ Web site address at
Information Collection: Essential Health http://www.cms.hhs.gov/
Agency Information Collection
Benefits in Alternative Benefit Plans, PaperworkReductionActof1995.
Activities: Proposed Collection; 2. Email your request, including your
Eligibility Notices, Fair Hearing and Comment Request address, phone number, OMB number,
Appeal Processes, and Premiums and
AGENCY: Centers for Medicare & and CMS document identifier, to
Cost Sharing; Exchanges: Eligibility and
Medicaid Services, HHS. Paperwork@cms.hhs.gov.
Enrollment; Use: The Patient Protection
ACTION: Notice. 3. Call the Reports Clearance Office at
and Affordable Care Act, Public Law
(410) 786–1326.
111–148, enacted on March 23, 2010,
SUMMARY: The Centers for Medicare & FOR FURTHER INFORMATION CONTACT:
and the Health Care and Education
Medicaid Services (CMS) is announcing Reports Clearance Office at (410) 786–
Reconciliation Act, Public Law 111–
an opportunity for the public to 1326.
152, expands access to health insurance
comment on CMS’ intention to collect
for individuals and employees of small SUPPLEMENTARY INFORMATION:
information from the public. Under the
businesses through the establishment of Contents
Paperwork Reduction Act of 1995 (the
new Affordable Insurance Exchanges
PRA), federal agencies are required to This notice sets out a summary of the
(Exchanges), including the Small
publish notice in the Federal Register use and burden associated with the
Business Health Options Program
concerning each proposed collection of following information collections. More
(SHOP). The Exchanges, which became
information (including each proposed detailed information can be found in
operational on January 1, 2014,
extension or reinstatement of an existing each collection’s supporting statement
enhanced competition in the health
collection of information) and to allow and associated materials (see
insurance market, expanded access to
60 days for public comment on the ADDRESSES).
affordable health insurance for millions
proposed action. Interested persons are CMS–10311 Medicare Program/Home
of Americans, and provided consumers
invited to send comments regarding our Health Prospective Payment System
with a place to easily compare and shop
burden estimates or any other aspect of Rate Update for Calendar Year 2010:
for health insurance coverage. The
this collection of information, including Physician Narrative Requirement and
reporting requirements and data
any of the following subjects: (1) The Supporting Regulation
collection in Medicaid, Children’s
necessity and utility of the proposed CMS–10242 Documentation
Health Insurance Programs, and
information collection for the proper Requirements Concerning Emergency
Exchanges: Essential Health Benefits in
performance of the agency’s functions; and Nonemergency Ambulance
Alternative Benefit Plans, Eligibility
(2) the accuracy of the estimated Transports Described in the
Notices, Fair Hearing and Appeal
burden; (3) ways to enhance the quality, Beneficiary Signature Regulations in
Processes, and Premiums and Cost
utility, and clarity of the information to 42 CFR 424.36(b)
Sharing; Exchanges: Eligibility and
be collected; and (4) the use of
Enrollment (CMS–2334–F) address: (1) Under the PRA (44 U.S.C. 3501–
automated collection techniques or
Standards related to notices, (2) 3520), federal agencies must obtain
other forms of information technology to
procedures for the verification of approval from the Office of Management
minimize the information collection
enrollment in an eligible employer- and Budget (OMB) for each collection of
burden.
sponsored plan and eligibility for information they conduct or sponsor.
qualifying coverage in an eligible DATES: Comments must be received by The term ‘‘collection of information’’ is
employer-sponsored plan; and (3) other September 27, 2016. defined in 44 U.S.C. 3502(3) and 5 CFR
eligibility and enrollment provisions to ADDRESSES: When commenting, please 1320.3(c) and includes agency requests
ebenthall on DSK5MVXVN1PROD with NOTICES
provide detail necessary for state reference the document identifier or or requirements that members of the
implementation. Form Number: CMS– OMB control number. To be assured public submit reports, keep records, or
10468 (OMB control number: 0938– consideration, comments and provide information to a third party.
1207); Frequency: Annually; Affected recommendations must be submitted in Section 3506(c)(2)(A) of the PRA
Public: Individuals, Households and any one of the following ways: requires federal agencies to publish a
Private Sector; Number of Respondents: 1. Electronically. You may send your 60-day notice in the Federal Register
13,200; Total Annual Responses: comments electronically to http:// concerning each proposed collection of
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Document Created: 2018-02-08 07:51:17
Document Modified: 2018-02-08 07:51:17
| 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 on the collection(s) of information must be received by the OMB desk officer by August 29, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 49984 |
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