81 FR 52877 - 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 154 (August 10, 2016)

Page Range		52877-52878
FR Document		2016-18986

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: 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 154 (Wednesday, August 10, 2016)

[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52877-52878]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10463 and CMS-10469]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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: 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 on the collection(s) of information must be received by 
the OMB desk officer by September 9, 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: 
OIRA_[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.

[[Page 52878]]


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: Revision of a currently 
approved collection; Title of Information Collection: Cooperative 
Agreement to Support Navigators in Federally-facilitated and State 
Partnership Exchanges; Use: Section 1311(i) of the Affordable Care Act 
requires Exchanges (Marketplaces) to establish a Navigator grant 
program as part of its function to provide consumers with assistance 
when they need it. Navigators will assist consumers by providing 
education about and facilitating selection of qualified health plans 
(QHPs) within Marketplaces, as well as other required duties. Section 
1311(i) requires that a Marketplace operating as of January 1, 2014, 
must establish a Navigator Program under which it awards grants to 
eligible individuals or entities who satisfy the requirements to be 
Exchange Navigators. For Federally-facilitated Marketplaces (FFMs) and 
State Partnership Marketplaces (SPMs), CMS will be awarding these 
grants. Navigator awardees must provide weekly, monthly, quarterly, and 
annual progress reports to CMS on the activities performed during the 
grant period and any sub-awardees receiving funds. CMS has modified the 
data collection requirements for the weekly, monthly, quarterly, and 
annual reports that were provided in 81 FR 29268 (May 11, 2016). Form 
Number: CMS-10463 (OMB control number: 0938-1215); Frequency: Annually; 
Quarterly; Monthly; Weekly; and Quarterly; Affected Public: Private 
sector; Number of Respondents: 102; Total Annual Responses: 102; 408; 
1,224; 5,304; Total Annual Hours: 24,729. (For policy questions 
regarding this collection, contact Gian Johnson at 301-492-4323.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Issuer Reporting 
Requirements for Selecting a Cost-Sharing Reductions Reconciliation 
Methodology; Use: Sections 1402 and 1412 of the Affordable Care Act 
provide for reductions in cost sharing on essential health benefits for 
low- and moderate-income enrollees in silver level qualified health 
plans (QHP) on individual market Exchanges. It also provides for 
reductions in cost sharing for Indians enrolled in QHPs at any metal 
level. These cost-sharing reductions will help eligible individuals and 
families afford the out-of-pocket spending associated with health care 
services provided through Exchange-based QHP coverage.
    The law directs QHP issuers to notify the Secretary of the 
Department of Health and Human Services (HHS) of cost-sharing 
reductions made under the statute for qualified individuals, and 
directs the Secretary to make periodic and timely payments to the QHP 
issuer equal to the value of those reductions. Further, the law permits 
advance payment of the cost-sharing reduction amounts to QHP issuers 
based upon amounts specified by the Secretary.
    Under established HHS regulations, QHP issuers will receive advance 
payments of the cost-sharing reductions throughout the year. Each 
issuer will then be subject to one of two reconciliation processes 
after the year to ensure that HHS reimbursed each issuer the correct 
cost-sharing portion of advance payments. This information collection 
request establishes the data collection requirements for a QHP issuer 
to report to HHS which reconciliation reporting option the issuer will 
be subject to for a given benefit year. Form Number: CMS-10469 (OMB 
control number: 0938-1214); Frequency: Annually; Affected Public: 
Private sector (Businesses or other for-profits); Number of 
Respondents: 575; Total Annual Responses: 575; Total Annual Hours: 
13,200. (For policy questions regarding this collection contact Pat 
Meisol at 410-786-1917.)

    Dated: August 5, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-18986 Filed 8-9-16; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices 52877

Background and Brief Description find Zika vectors based on historical and sub-county-level records for Aedes
The Zika virus response necessitates records and environmental suitability. It aegypti and Ae. albopictus, the vectors
the collection of county and sub-county is likely that the reason for this is of Zika virus. The resulting maps and
level records for Aedes aegypti and Ae. because from 2004–2015 most vector models will: Inform the public and
albopictus, the vectors of Zika virus. surveillance focused on vectors of West policy makers of the known distribution
This information will be used to update Nile virus (Culex spp.) rather than Zika of these vectors, identify gaps in vector
species distribution maps for the United vectors. As part of the Zika response, surveillance, and target allocation of
States and to develop a model aimed at efforts to identify Ae. aegypti and Ae. surveillance and prevention resources.
identifying where these vectors can albopictus in the continental U.S. were Respondents will include vector
survive and reproduce. CDC is seeking substantially enhanced during 2016 and control professionals, entomologists,
six months of OMB clearance to collect funding will be provided to states to and public health professionals who
information. continue to enhance surveillance for will be contacted by email, primarily
In February, 2016, OMB issued these vectors. By repeating the survey, through listserves of professional
emergency clearance for a county-level we will have a more complete organizations. They will be asked for
survey of vector surveillance records assessment of where these vectors are their voluntary participation in a short
(OMB Control No. 0920–1101, currently being reported. In the new survey to assess the distribution of
expiration date 8/31/2016). This survey, we will also seek information on Aedes aegypti and Aedes albopictus at
information collection will be nearly a locations of the mosquito traps at sub- county and sub-county spatial scales in
repeat of that survey. county spatial scales. Such information the U.S.
The previous survey aimed to will aid in (1) targeting vector control This information collection request is
describe the current reported efforts to prevent mosquito-borne Zika authorized by Section 301 of the Public
distribution of the Zika virus vectors virus transmission in the continental Health Service Act (42 U.S.C. 241). The
Aedes aegypti and Ae. albopictus. The U.S. and (2) targeting future vector total estimated annualized number of
survey revealed that we are lacking surveillance efforts. burden hours is 125. There will be no
records from recent years of both The purpose of the mosquito anticipated costs to respondents other
species from areas where we expect to surveillance survey is to collect county than time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs.)
respondent (in hrs.)

Vector control professionals, ento- Survey of county-level surveillance 500 1 15/60 125
mologists, and Public health bi- records of Aedes aegypti and
ologists. Aedes albopictus.
Total ......................................... ........................................................ ........................ ............................ ........................ 125

Jeffrey M. Zirger, information from the public. Under the ADDRESSES: When commenting on the
Health Scientist, Acting Chief, Information Paperwork Reduction Act of 1995 proposed information collections,
Collection Review Office, Office of Scientific (PRA), federal agencies are required to please reference the document identifier
Integrity, Office of the Associate Director for publish notice in the Federal Register or OMB control number. To be assured
Science, Office of the Director, Centers for concerning each proposed collection of consideration, comments and
Disease Control and Prevention. recommendations must be received by
information, including each proposed
[FR Doc. 2016–18936 Filed 8–9–16; 8:45 am] the OMB desk officer via one of the
extension or reinstatement of an existing
BILLING CODE 4163–18–P collection of information, and to allow following transmissions: OMB, Office of
a second opportunity for public Information and Regulatory Affairs,
comment on the notice. Interested Attention: CMS Desk Officer, Fax
DEPARTMENT OF HEALTH AND Number: (202) 395–5806 OR, Email:
persons are invited to send comments
HUMAN SERVICES OIRA_submission@omb.eop.gov.
regarding the burden estimate or any
other aspect of this collection of To obtain copies of a supporting
Centers for Medicare & Medicaid
information, including any of the statement and any related forms for the
Services
following subjects: The necessity and proposed collection(s) summarized in
[Document Identifier: CMS–10463 and CMS– utility of the proposed information this notice, you may make your request
10469] collection for the proper performance of using one of following:
the agency’s functions; the accuracy of 1. Access CMS’ Web site address at
Agency Information Collection http://www.cms.hhs.gov/Paperwork
Activities: Submission for OMB the estimated burden; ways to enhance
the quality, utility, and clarity of the ReductionActof1995.
Review; Comment Request 2. Email your request, including your
information to be collected; and the use
address, phone number, OMB number,
mstockstill on DSK3G9T082PROD with NOTICES

AGENCY: Centers for Medicare & of automated collection techniques or
Medicaid Services. other forms of information technology to and CMS document identifier, to
ACTION: Notice. minimize the information collection Paperwork@cms.hhs.gov.
burden. 3. Call the Reports Clearance Office at
SUMMARY: The Centers for Medicare & (410) 786–1326.
Medicaid Services (CMS) is announcing DATES:Comments on the collection(s) of FOR FURTHER INFORMATION CONTACT:
an opportunity for the public to information must be received by the Reports Clearance Office at (410) 786–
comment on CMS’ intention to collect OMB desk officer by September 9, 2016. 1326.

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52878 Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices

SUPPLEMENTARY INFORMATION: Under the provided in 81 FR 29268 (May 11, Number of Respondents: 575; Total
Paperwork Reduction Act of 1995 (PRA) 2016). Form Number: CMS–10463 (OMB Annual Responses: 575; Total Annual
(44 U.S.C. 3501–3520), federal agencies control number: 0938–1215); Frequency: Hours: 13,200. (For policy questions
must obtain approval from the Office of Annually; Quarterly; Monthly; Weekly; regarding this collection contact Pat
Management and Budget (OMB) for each and Quarterly; Affected Public: Private Meisol at 410–786–1917.)
collection of information they conduct sector; Number of Respondents: 102; Dated: August 5, 2016.
or sponsor. The term ‘‘collection of Total Annual Responses: 102; 408;
William N. Parham, III,
information’’ is defined in 44 U.S.C. 1,224; 5,304; Total Annual Hours:
Director, Paperwork Reduction Staff, Office
3502(3) and 5 CFR 1320.3(c) and 24,729. (For policy questions regarding
of Strategic Operations and Regulatory
includes agency requests or this collection, contact Gian Johnson at Affairs.
requirements that members of the public 301–492–4323.)
[FR Doc. 2016–18986 Filed 8–9–16; 8:45 am]
submit reports, keep records, or provide 2. Type of Information Collection
BILLING CODE 4120–01–P
information to a third party. Section Request: Extension of a currently
3506(c)(2)(A) of the PRA (44 U.S.C. approved collection; Title of
3506(c)(2)(A)) requires federal agencies Information Collection: Issuer Reporting
Requirements for Selecting a Cost- DEPARTMENT OF HEALTH AND
to publish a 30-day notice in the HUMAN SERVICES
Federal Register concerning each Sharing Reductions Reconciliation
proposed collection of information, Methodology; Use: Sections 1402 and Food and Drug Administration
including each proposed extension or 1412 of the Affordable Care Act provide
reinstatement of an existing collection for reductions in cost sharing on [Docket Nos. FDA–2014–N–1721; FDA–
of information, before submitting the essential health benefits for low- and 2012–N–0248; FDA–2011–N–0449; FDA–
collection to OMB for approval. To moderate-income enrollees in silver 2012–N–0748; FDA–2012–N–0961; FDA–
comply with this requirement, CMS is level qualified health plans (QHP) on 2012–N–0921; FDA–2014–N–0189; FDA–
individual market Exchanges. It also 2004–N–0258]
publishing this notice that summarizes
the following proposed collection(s) of provides for reductions in cost sharing
for Indians enrolled in QHPs at any Agency Information Collection
information for public comment: Activities; Announcement of Office of
metal level. These cost-sharing
1. Type of Information Collection reductions will help eligible individuals Management and Budget Approvals
Request: Revision of a currently and families afford the out-of-pocket
approved collection; Title of AGENCY: Food and Drug Administration,
spending associated with health care HHS.
Information Collection: Cooperative services provided through Exchange-
Agreement to Support Navigators in ACTION: Notice.
based QHP coverage.
Federally-facilitated and State The law directs QHP issuers to notify
Partnership Exchanges; Use: Section SUMMARY: The Food and Drug
the Secretary of the Department of Administration (FDA) is publishing a
1311(i) of the Affordable Care Act Health and Human Services (HHS) of
requires Exchanges (Marketplaces) to list of information collections that have
cost-sharing reductions made under the been approved by the Office of
establish a Navigator grant program as statute for qualified individuals, and
part of its function to provide Management and Budget (OMB) under
directs the Secretary to make periodic the Paperwork Reduction Act of 1995.
consumers with assistance when they and timely payments to the QHP issuer
need it. Navigators will assist FOR FURTHER INFORMATION CONTACT: FDA
equal to the value of those reductions.
consumers by providing education Further, the law permits advance PRA Staff, Office of Operations, Food
about and facilitating selection of payment of the cost-sharing reduction and Drug Administration, Three White
qualified health plans (QHPs) within amounts to QHP issuers based upon Flint North, 10A63, 11601 Landsdown
Marketplaces, as well as other required amounts specified by the Secretary. St., North Bethesda, MD 20852,
duties. Section 1311(i) requires that a Under established HHS regulations, PRAStaff@fda.hhs.gov.
Marketplace operating as of January 1, QHP issuers will receive advance SUPPLEMENTARY INFORMATION: The
2014, must establish a Navigator payments of the cost-sharing reductions following is a list of FDA information
Program under which it awards grants throughout the year. Each issuer will collections recently approved by OMB
to eligible individuals or entities who then be subject to one of two under section 3507 of the Paperwork
satisfy the requirements to be Exchange reconciliation processes after the year to Reduction Act of 1995 (44 U.S.C. 3507).
Navigators. For Federally-facilitated ensure that HHS reimbursed each issuer The OMB control number and
Marketplaces (FFMs) and State the correct cost-sharing portion of expiration date of OMB approval for
Partnership Marketplaces (SPMs), CMS advance payments. This information each information collection are shown
will be awarding these grants. Navigator collection request establishes the data in table 1. Copies of the supporting
awardees must provide weekly, collection requirements for a QHP issuer statements for the information
monthly, quarterly, and annual progress to report to HHS which reconciliation collections are available on the Internet
reports to CMS on the activities reporting option the issuer will be at http://www.reginfo.gov/public/do/
performed during the grant period and subject to for a given benefit year. Form PRAMain. An Agency may not conduct
any sub-awardees receiving funds. CMS Number: CMS–10469 (OMB control or sponsor, and a person is not required
has modified the data collection number: 0938–1214); Frequency: to respond to, a collection of
requirements for the weekly, monthly, Annually; Affected Public: Private information unless it displays a
quarterly, and annual reports that were sector (Businesses or other for-profits); currently valid OMB control number.
mstockstill on DSK3G9T082PROD with NOTICES

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires

Investigational New Drug Regulations .................................................................................................................... 0910–0014 2/28/2019

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Document Created: 2016-08-10 01:59:36
Document Modified: 2016-08-10 01:59:36

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 September 9, 2016.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 52877

81 FR 52877 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 154 (August 10, 2016)

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