81 FR 76358 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 212 (November 2, 2016)

Page Range		76358-76359
FR Document		2016-26493

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: 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.

Federal Register, Volume 81 Issue 212 (Wednesday, November 2, 2016)

[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76358-76359]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10632]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services.

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 (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: 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 January 3, 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-10632 Evaluating Coverage to Care (C2C)

    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 collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluating Coverage to Care (C2C); Use: CMS OMH has contracted with the 
RAND Corporation to evaluate From Coverage to Care (C2C). From the 
beginning of the Affordable Care Act's implementation, the Centers for 
Medicare & Medicaid Services, Office of Minority Health (CMS OMH) 
recognized that achieving better health and reduced health care costs 
would require individuals to take an active role in their health care 
and regularly use primary and preventive care services. To address this 
need, CMS OMH launched From Coverage to Care (C2C) in June 2014. C2C 
was designed to help consumers understand what it means to have health 
insurance coverage, how to find a provider, when and where to seek 
appropriate health services, and why prevention and partnering with a 
provider is important for achieving optimal health. It was also 
designed to equip health care providers and stakeholders in the 
community who support consumers' connection to care with the tools 
needed to promote consumer engagement and to promote changes in the 
health care system that improve access to care. As part of C2C, CMS 
produced a range of consumer-oriented materials, both web-based and in 
print. The most in-depth of the print materials is an eight-step 
booklet titled ``A Roadmap to Better Care and a Healthier You.'' Based 
on the need for the information to be communicated in smaller, more 
digestible packets, booklets were developed to correspond to each of 
the eight steps. Four of the most popular pages of the Roadmap have 
been made available as single-page handouts for easier distribution. 
These materials are currently available in eight languages, including 
English, Spanish, Arabic, Chinese, Haitian Creole, Korean, Russian, and 
Vietnamese.
    Since the national launch in 2014, CMS has disseminated C2C through 
speaking engagements, webinars, and meetings sponsored by CMS regional 
offices. CMS fills product orders and recently completed a redesign of 
the C2C Web site. C2C has grown to address emerging needs of consumers, 
as well as stakeholders or organizations that work with and support 
consumers, across the full continuum of health insurance and care: Plan 
selection, enrollment, finding a provider, and engaging in care over 
time.
    RAND spent the past year designing and preparing for this 
evaluation to assess C2C's impact on consumer health insurance literacy 
and care utilization. This evaluation will also help CMS understand how 
C2C is spread within a community and disseminated to consumers, and in 
turn how best to

[[Page 76359]]

maximize C2C's impact. The next three years will be dedicated to 
implementing the evaluation described in this submission. We are 
proposing four data collection activities: (1) A cross-sectional survey 
of organizations that have ordered and used the materials with 
consumers; (2) A cross-sectional survey of consumers, drawn from the 
Knowledge Networks panel, to measure the association between C2C and 
consumer knowledge and behavior; (3) semi-structured interviews with 
staff from a limited set of community organizations as part of a case 
study; and (4) focus groups of consumers as part of a case study. The 
case study will be conducted in a community where English is not the 
preferred language, and where C2C materials in another language (e.g., 
Spanish, Arabic, Chinese, Haitian Creole, Korean, Russian, and 
Vietnamese) were used with consumers. Form Number: CMS-10632 (OMB 
control number: 0938-New); Frequency: Occasionally; Affected Public: 
Individuals or Households; Number of Respondents: 3,460; Total Annual 
Responses: 3,460; Total Annual Hours: 1,176. (For policy questions 
regarding this collection contact Ashley Peddicord-Austin at 410-786-
0757).

    Dated: October 28, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-26493 Filed 11-1-16; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices 76359

maximize C2C’s impact. The next three DATES: Fax written comments on the concluded that such trials exist. If there
years will be dedicated to implementing collection of information by December are no cardiovascular outcome data to
the evaluation described in this 2, 2016. cite, one of the following two
submission. We are proposing four data ADDRESSES: To ensure that comments on paragraphs should appear:
collection activities: (1) A cross- the information collection are received, ‘‘There are no trials of [DRUGNAME]
sectional survey of organizations that OMB recommends that written or members of the [name of
have ordered and used the materials comments be faxed to the Office of pharmacologic class] pharmacologic
with consumers; (2) A cross-sectional Information and Regulatory Affairs, class demonstrating reductions in
survey of consumers, drawn from the OMB, Attn: FDA Desk Officer, FAX: cardiovascular risk in patients with
Knowledge Networks panel, to measure 202–395–7285, or emailed to oira_ hypertension,’’ or ‘‘There are no trials of
the association between C2C and submission@omb.eop.gov. All [DRUGNAME] demonstrating
consumer knowledge and behavior; (3) comments should be identified with the reductions in cardiovascular risk in
semi-structured interviews with staff OMB control number 0910–0670. Also patients with hypertension, but at least
from a limited set of community include the FDA docket number found one pharmacologically similar drug has
organizations as part of a case study; in brackets in the heading of this demonstrated such benefits.’’
and (4) focus groups of consumers as document. In the latter case, the applicant’s
part of a case study. The case study will submission generally should refer to
Guidance for Industry on Hypertension table 1 in section V of the guidance. If
be conducted in a community where
Indication: Drug Labeling for the applicant believes that table 1 is
English is not the preferred language, Cardiovascular Outcome Claims; OMB
and where C2C materials in another incomplete, it should submit the
Control Number 0910–0670—Extension clinical evidence for the additional
language (e.g., Spanish, Arabic, Chinese,
Haitian Creole, Korean, Russian, and This guidance is intended to assist information to Docket No. FDA–2008–
Vietnamese) were used with consumers. applicants in developing labeling for D–0150. The labeling submission
Form Number: CMS–10632 (OMB outcome claims for drugs that are should reference the submission to the
control number: 0938-New); Frequency: indicated to treat hypertension. With docket. FDA estimates that no more
Occasionally; Affected Public: few exceptions, current labeling for than one submission to the docket will
Individuals or Households; Number of antihypertensive drugs includes only be made annually from one company,
Respondents: 3,460; Total Annual the information that these drugs are and that each submission will take
Responses: 3,460; Total Annual Hours: indicated to reduce blood pressure; the approximately 10 hours to prepare and
1,176. (For policy questions regarding labeling does not include information submit. Concerning the
this collection contact Ashley on the clinical benefits related to recommendations for the CLINICAL
Peddicord-Austin at 410–786–0757). cardiovascular outcomes expected from STUDIES section of the Full Prescribing
such blood pressure reduction. Information of the labeling, FDA
Dated: October 28, 2016. However, blood pressure control is well regulations at §§ 201.56 and 201.57 (21
William N. Parham, III, established as beneficial in preventing CFR 201.56 and 201.57) require such
Director, Paperwork Reduction Staff, Office serious cardiovascular events, and labeling, and the information collection
of Strategic Operations and Regulatory inadequate treatment of hypertension is associated with these regulations is
Affairs. acknowledged as a significant public approved by OMB under OMB control
[FR Doc. 2016–26493 Filed 11–1–16; 8:45 am] health problem. FDA believes that the number 0910–0572.
BILLING CODE 4120–01–P appropriate use of these drugs can be 2. Section VI.B of the guidance
encouraged by making the connection requests that the format of
between lower blood pressure and cardiovascular outcome claim prior
DEPARTMENT OF HEALTH AND improved cardiovascular outcomes approval supplements submitted to FDA
HUMAN SERVICES more explicit in labeling. The intent of under the guidance should include the
the guidance is to provide common following information:
Food and Drug Administration labeling for antihypertensive drugs • A statement that the submission is
except where differences are clearly a cardiovascular outcome claim
[Docket No. FDA–2010–N–0117] supported by clinical data. The supplement, with reference to the
guidance encourages applicants to guidance and related Docket No. FDA–
Agency Information Collection submit labeling supplements containing 2008–D–0150.
Activities; Submission for Office of the new language. • Applicable FDA forms (e.g., 356h,
Management and Budget Review; The guidance contains two provisions 3397).
Comment Request; Guidance for that are subject to OMB review and • Detailed table of contents.
Industry on Hypertension Indication: approval under the PRA and one • Revised labeling to:
Drug Labeling for Cardiovascular provision that would be exempt from Æ Include draft revised labeling
Outcome Claims OMB review: conforming to the requirements in
1. Section IV.C of the guidance §§ 201.56 and 201.57 and
AGENCY: Food and Drug Administration, requests that the CLINICAL STUDIES Æ include marked-up copy of the
HHS. section of the Full Prescribing latest approved labeling, showing all
ACTION: Notice. Information of the labeling should additions and deletions, with
include a summary of placebo or active- annotations of where supporting data (if
SUMMARY: The Food and Drug controlled trials showing evidence of
sradovich on DSK3GMQ082PROD with NOTICES

applicable) are located in the
Administration (FDA or we) is the specific drug’s effectiveness in submission.
announcing that a proposed collection lowering blood pressure. If trials FDA estimates that approximately 1
of information has been submitted to the demonstrating cardiovascular outcome cardiovascular outcome claim
Office of Management and Budget benefits exist, those trials also should be supplement will be submitted annually
(OMB) for review and clearance under summarized in this section. Table 1 in from approximately 1 different
the Paperwork Reduction Act of 1995 Section V of the guidance contains the companies, and that each supplement
(the PRA). specific drugs for which FDA has will take approximately 20 hours to

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Document Created: 2016-11-02 01:40:57
Document Modified: 2016-11-02 01:40:57

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 3, 2017.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 76358

81 FR 76358 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 212 (November 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services