Agency Information Collection Activities: Submission for OMB Review; Comment Request, 11569-11571 [2016-04841]

Download as PDF 11569 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices and guidance for programs addressing IVP have been provided through cooperative agreement funding and technical assistance administered by NCIPC. Awardees report progress and activity information to NCIPC on an annual schedule using three documents: Annual Progress Report, Evaluation and Performance Management Plan, and Injury Indicator Spreadsheet. Burden is expected to vary based on awardee funding type. For example all awardees who successfully compete will be funded for the BASE component. However, awardees will also have the opportunity to compete to be funded for one or both of the Enhanced components. It is expected that those funded for Enhanced components will have a greater burden, given the requirement to report on more domains of activity. Information to be collected will provide crucial data for program performance monitoring and provide CDC with the capacity to respond in a timely manner to requests for information about the program from the Department of Health and Human Services (HHS), the White House, Congress, and other sources. Information to be collected will also strengthen CDC’s ability to monitor awardee progress, provide data-driven technical assistance, and disseminate the most current surveillance data on unintentional and intentional injuries. The total estimated annualized burden for this collection is 3,120 hours. OMB approval is requested for three years. The only cost to respondents will be time spent on responding to the progress reports. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Type of respondents Form name Core SVIPP BASE Awardees ......................... 20 20 20 1 1 1 22 11 2 Component Initial Population—Annual Progress Report .. Annual Progress Report ................................. Evaluation and Performance Management Plan. Injury Indicator Spreadsheet .......................... Initial Population—Annual Progress Report .. 20 5 1 1 14 73 5 5 1 1 58 3 Component Annual Progress Report ................................. Evaluation and Performance Management Plan. Injury Indicator Spreadsheet .......................... Initial Population—Annual Progress Report .. 5 5 1 1 14 146 5 5 1 1 116 4 5 1 14 Core SVIPP Awardees. 1—Enhanced Core SVIPP Awardees. 2—Enhanced Annual Progress Report ................................. Evaluation and Performance Management Plan. Injury Indicator Spreadsheet .......................... Leroy A. Richardson, 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. 2016–04796 Filed 3–3–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10110, CMS– 10387, CMS–10400 and CMS–10593] jstallworth on DSK7TPTVN1PROD with NOTICES Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. 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 SUMMARY: VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 (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. Comments on the collection(s) of information must be received by the OMB desk officer by April 4, 2016. DATES: When commenting on the proposed information collections, ADDRESSES: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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. E:\FR\FM\04MRN1.SGM 04MRN1 11570 Federal Register / Vol. 81, No. 43 / Friday, March 4, 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: Reinstatement of a previously approved collection; Title of Information Collection: Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; Use: We are requesting approval of a reinstatement of a Change of Therapy OMRA for Skilled Nursing Facilities (SNFs). As described in CMS–1351–F, we finalized the assessment effective October 1, 2011. The SNFs are required to submit this assessment. The COT OMRA is comprised of a subset of resident assessment information developed for use by SNFs to satisfy a Medicare payment requirement. The burden associated with this is the SNF staff time required to complete the COT OMRA, SNF staff time to encode the data, and SNF staff time spent in transmitting the data. The SNFs are required to complete a COT OMRA when a SNF resident was receiving a sufficient level of rehabilitation therapy to qualify for an Ultra High, Very High, High, Medium, or Low Rehabilitation category and when the intensity of therapy (as indicated by the total reimbursable therapy minutes (RTM) delivered, and other therapy qualifiers such as number of therapy days and disciplines providing therapy) changes to such a degree that it would no longer reflect the RUG–IV classification and payment assigned for a given SNF resident based on the most recent assessment used for Medicare payment. The COT OMRA is a type of required PPS assessment which uses the same item set as the End of Therapy (EOT) OMRA. Form Number: CMS–10387 jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 (OMB Control Number: 0938–1140); Frequency: Yearly; Affected Public: Private sector (Business or other Forprofits and Not-for-profit institutions); Number of Respondents: 15,421; Total Annual Responses: 678,524; Total Annual Hours: 701,119. (For policy questions regarding this collection contact Penny Gershman at 410–786– 6643). 2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Use: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price (ASP) of the drug or biological, beginning in Calendar Year (CY) 2005. The ASP data reporting requirements are specified in Section 1927 of the Act. The reported ASP data are used to establish the Medicare payment amounts. The reporting template was revised in CY 2011 in order to facilitate accurate collection of ASP data. An accompanying user guide with instructions on the template’s use was also created and included an explanation of the data elements in the template. Form Number: CMS–10110 (OMB Control Number: 0938–0921); Frequency: Quarterly; Affected Public: Private sector (Business or other Forprofits); Number of Respondents: 180; Total Annual Responses: 720; Total Annual Hours: 34,560. (For policy questions regarding this collection contact Amy Gruber at 410–786–1542). 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Establishment of Exchanges and Qualified Health Plans; 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, enacted on March 30, 2010 (collectively, ‘‘Affordable Care Act’’), expand 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). As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange will assume responsibilities related to the PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and nondiscrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR parts 155 and 156, based on the Affordable Care Act, as well as other standards determined by the Exchange. The reporting requirements and data collection in the Exchange rule address Federal requirements that various entities must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a State based or Federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. This proposed information collection was published in the Federal Register on November 23, 2015 (80 FR 72968). No comments were received. Form Number: CMS–10400; Frequency: Monthly, Annual; Affected Public: Private Sector; Number of Respondents: 11,004; Number of Responses: 11,485; Total Annual Hours: 55,775. (For policy questions regarding this collection, contact Leigha Basini at 301–492–4380.) 4. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Establishment of an Exchange by a State and Qualified Health Plans; 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, enacted on March 30, 2010 (collectively, ‘‘Affordable Care Act’’), expand 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). As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange will assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans E:\FR\FM\04MRN1.SGM 04MRN1 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and nondiscrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR parts 155 and 156, based on the Affordable Care Act, as well as other standards determined by the Exchange. The reporting requirements and data collection in the Exchange rule address Federal requirements that various entities must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a State based or Federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. Comments have been received, however; there were no comments that impacted the burden, and therefore no additional changes were made. Form Number: CMS–10593 (OMB Control Number: 0938–NEW); Frequency: Annually, Monthly; Affected Public: Private Sector; Business or other forprofit; Number of Respondents: 20; Total Annual Responses: 400; Total Annual Hours: 36,900. (For policy questions regarding this collection contact Christy Woods at 301–492– 5140.) Dated: March 1, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016–04841 Filed 3–3–16; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10152] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. jstallworth on DSK7TPTVN1PROD with NOTICES AGENCY: 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 SUMMARY: VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PRA), federal agencies are require; 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: (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. Comments must be received by May 3, 2016. 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 https:// 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 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. DATES: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 11571 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–10152 Data Collection for Medicare Beneficiaries Receiving NaF– 18 Positron Emission Tomography (PET) To Identify Bone Metastasis in Cancer 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. 1. Type of Information Collection Request: Extension of a previously approved collection; Title: Data Collection for Medicare Beneficiaries Receiving NaF–18 Positron Emission Tomography (PET) to Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG–00065R, issued on February 26, 2010, the Centers for Medicare and Medicaid Services (CMS) determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving NaF–18 PET scan to identify bone metastasis in cancer is reasonable and necessary only when the provider is participating in and patients are enrolled in a clinical study designed to information at the time of the scan to assist in initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in beneficiaries in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11569-11571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04841]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110, CMS-10387, CMS-10400 and CMS-10593]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

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 April 4, 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 11570]]


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: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Skilled Nursing Facility (SNF) Prospective Payment System and 
Consolidated Billing; Use: We are requesting approval of a 
reinstatement of a Change of Therapy OMRA for Skilled Nursing 
Facilities (SNFs). As described in CMS-1351-F, we finalized the 
assessment effective October 1, 2011. The SNFs are required to submit 
this assessment. The COT OMRA is comprised of a subset of resident 
assessment information developed for use by SNFs to satisfy a Medicare 
payment requirement. The burden associated with this is the SNF staff 
time required to complete the COT OMRA, SNF staff time to encode the 
data, and SNF staff time spent in transmitting the data. The SNFs are 
required to complete a COT OMRA when a SNF resident was receiving a 
sufficient level of rehabilitation therapy to qualify for an Ultra 
High, Very High, High, Medium, or Low Rehabilitation category and when 
the intensity of therapy (as indicated by the total reimbursable 
therapy minutes (RTM) delivered, and other therapy qualifiers such as 
number of therapy days and disciplines providing therapy) changes to 
such a degree that it would no longer reflect the RUG-IV classification 
and payment assigned for a given SNF resident based on the most recent 
assessment used for Medicare payment. The COT OMRA is a type of 
required PPS assessment which uses the same item set as the End of 
Therapy (EOT) OMRA. Form Number: CMS-10387 (OMB Control Number: 0938-
1140); Frequency: Yearly; Affected Public: Private sector (Business or 
other For-profits and Not-for-profit institutions); Number of 
Respondents: 15,421; Total Annual Responses: 678,524; Total Annual 
Hours: 701,119. (For policy questions regarding this collection contact 
Penny Gershman at 410-786-6643).
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare 
Part B Drugs and Biologicals; Use: In accordance with Section 1847A of 
the Social Security Act (the Act), Medicare Part B covered drugs and 
biologicals not paid on a cost or prospective payment basis are paid 
based on the average sales price (ASP) of the drug or biological, 
beginning in Calendar Year (CY) 2005. The ASP data reporting 
requirements are specified in Section 1927 of the Act. The reported ASP 
data are used to establish the Medicare payment amounts. The reporting 
template was revised in CY 2011 in order to facilitate accurate 
collection of ASP data. An accompanying user guide with instructions on 
the template's use was also created and included an explanation of the 
data elements in the template. Form Number: CMS-10110 (OMB Control 
Number: 0938-0921); Frequency: Quarterly; Affected Public: Private 
sector (Business or other For-profits); Number of Respondents: 180; 
Total Annual Responses: 720; Total Annual Hours: 34,560. (For policy 
questions regarding this collection contact Amy Gruber at 410-786-
1542).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Establishment of 
Exchanges and Qualified Health Plans; 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, 
enacted on March 30, 2010 (collectively, ``Affordable Care Act''), 
expand 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).
    As directed by the rule Establishment of Exchanges and Qualified 
Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange 
rule), each Exchange will assume responsibilities related to the 
certification and offering of Qualified Health Plans (QHPs). To offer 
insurance through an Exchange, a health insurance issuer must have its 
health plans certified as QHPs by the Exchange. A QHP must meet certain 
minimum certification standards, such as network adequacy, inclusion of 
Essential Community Providers (ECPs), and non-discrimination. The 
Exchange is responsible for ensuring that QHPs meet these minimum 
certification standards as described in the Exchange rule under 45 CFR 
parts 155 and 156, based on the Affordable Care Act, as well as other 
standards determined by the Exchange. The reporting requirements and 
data collection in the Exchange rule address Federal requirements that 
various entities must meet with respect to the establishment and 
operation of an Exchange; minimum requirements that health insurance 
issuers must meet with respect to participation in a State based or 
Federally-facilitated Exchange; and requirements that employers must 
meet with respect to participation in the SHOP and compliance with 
other provisions of the Affordable Care Act. This proposed information 
collection was published in the Federal Register on November 23, 2015 
(80 FR 72968). No comments were received. Form Number: CMS-10400; 
Frequency: Monthly, Annual; Affected Public: Private Sector; Number of 
Respondents: 11,004; Number of Responses: 11,485; Total Annual Hours: 
55,775. (For policy questions regarding this collection, contact Leigha 
Basini at 301-492-4380.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Establishment of an Exchange by a State and Qualified Health Plans; 
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, enacted on March 30, 2010 
(collectively, ``Affordable Care Act''), expand 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). As directed 
by the rule Establishment of Exchanges and Qualified Health Plans; 
Exchange Standards for Employers (77 FR 18310) (Exchange rule), each 
Exchange will assume responsibilities related to the certification and 
offering of Qualified Health Plans (QHPs). To offer insurance through 
an Exchange, a health insurance issuer must have its health plans

[[Page 11571]]

certified as QHPs by the Exchange. A QHP must meet certain minimum 
certification standards, such as network adequacy, inclusion of 
Essential Community Providers (ECPs), and non-discrimination. The 
Exchange is responsible for ensuring that QHPs meet these minimum 
certification standards as described in the Exchange rule under 45 CFR 
parts 155 and 156, based on the Affordable Care Act, as well as other 
standards determined by the Exchange. The reporting requirements and 
data collection in the Exchange rule address Federal requirements that 
various entities must meet with respect to the establishment and 
operation of an Exchange; minimum requirements that health insurance 
issuers must meet with respect to participation in a State based or 
Federally-facilitated Exchange; and requirements that employers must 
meet with respect to participation in the SHOP and compliance with 
other provisions of the Affordable Care Act. Comments have been 
received, however; there were no comments that impacted the burden, and 
therefore no additional changes were made. Form Number: CMS-10593 (OMB 
Control Number: 0938-NEW); Frequency: Annually, Monthly; Affected 
Public: Private Sector; Business or other for-profit; Number of 
Respondents: 20; Total Annual Responses: 400; Total Annual Hours: 
36,900. (For policy questions regarding this collection contact Christy 
Woods at 301-492-5140.)

    Dated: March 1, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-04841 Filed 3-3-16; 8:45 am]
BILLING CODE 4120-01-P
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