[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49984-49985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17988]


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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.

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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