Agency Information Collection Activities: Submission for OMB Review; Comment Request, 52877-52878 [2016-18986]

Download as PDF 52877 Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices Background and Brief Description The Zika virus response necessitates the collection of county and sub-county level records for Aedes aegypti and Ae. albopictus, the vectors of Zika virus. This information will be used to update species distribution maps for the United States and to develop a model aimed at identifying where these vectors can survive and reproduce. CDC is seeking six months of OMB clearance to collect information. In February, 2016, OMB issued emergency clearance for a county-level survey of vector surveillance records (OMB Control No. 0920–1101, expiration date 8/31/2016). This information collection will be nearly a repeat of that survey. The previous survey aimed to describe the current reported distribution of the Zika virus vectors Aedes aegypti and Ae. albopictus. The survey revealed that we are lacking records from recent years of both species from areas where we expect to find Zika vectors based on historical records and environmental suitability. It is likely that the reason for this is because from 2004–2015 most vector surveillance focused on vectors of West Nile virus (Culex spp.) rather than Zika vectors. As part of the Zika response, efforts to identify Ae. aegypti and Ae. albopictus in the continental U.S. were substantially enhanced during 2016 and funding will be provided to states to continue to enhance surveillance for these vectors. By repeating the survey, we will have a more complete assessment of where these vectors are currently being reported. In the new survey, we will also seek information on locations of the mosquito traps at subcounty spatial scales. Such information will aid in (1) targeting vector control efforts to prevent mosquito-borne Zika virus transmission in the continental U.S. and (2) targeting future vector surveillance efforts. The purpose of the mosquito surveillance survey is to collect county and sub-county-level records for Aedes aegypti and Ae. albopictus, the vectors of Zika virus. The resulting maps and models will: Inform the public and policy makers of the known distribution of these vectors, identify gaps in vector surveillance, and target allocation of surveillance and prevention resources. Respondents will include vector control professionals, entomologists, and public health professionals who will be contacted by email, primarily through listserves of professional organizations. They will be asked for their voluntary participation in a short survey to assess the distribution of Aedes aegypti and Aedes albopictus at county and sub-county spatial scales in the U.S. This information collection request is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241). The total estimated annualized number of burden hours is 125. There will be no anticipated costs to respondents other than time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hrs.) Number of responses per respondent Total burden (in hrs.) Type of respondents Form name Vector control professionals, entomologists, and Public health biologists. Survey of county-level surveillance records of Aedes aegypti and Aedes albopictus. 500 1 15/60 125 Total ......................................... ........................................................ ........................ ............................ ........................ 125 Jeffrey M. Zirger, Health Scientist, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016–18936 Filed 8–9–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10463 and CMS– 10469] mstockstill on DSK3G9T082PROD with NOTICES Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect SUMMARY: VerDate Sep<11>2014 17:34 Aug 09, 2016 Jkt 238001 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. Comments on the collection(s) of information must be received by the OMB desk officer by September 9, 2016. DATES: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 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_submission@omb.eop.gov. 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 https://www.cms.hhs.gov/Paperwork ReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. ADDRESSES: E:\FR\FM\10AUN1.SGM 10AUN1 52878 Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices 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 mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: 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 CostSharing 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 Exchangebased 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2014–N–1721; FDA– 2012–N–0248; FDA–2011–N–0449; FDA– 2012–N–0748; FDA–2012–N–0961; FDA– 2012–N–0921; FDA–2014–N–0189; FDA– 2004–N–0258] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUMMARY: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Investigational New Drug Regulations .................................................................................................................... VerDate Sep<11>2014 17:34 Aug 09, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1 0910–0014 Date approval expires 2/28/2019

Agencies

[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52877-52878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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_submission@omb.eop.gov.
    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 https://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    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

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