80 FR 72066 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 222 (November 18, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 222 (November 18, 2015)
| Page Range | 72066-72067 | |
| FR Document | 2015-29343 |
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)] [Notices] [Pages 72066-72067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29343] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10433] 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 December 18, 2015: ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs Attention: CMS Desk Officer Fax Number: (202) 395-5806 OR Email: [email protected] To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved information collection; Title of Information Collection: Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations; Use: As required by the CMS-9989-F, Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange Establishment Rule), published on March 27, 2012, each Exchange must 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 those pertaining to essential community providers, essential health benefits, and actuarial value. In order to meet those standards, the Exchange is responsible for collecting data and validating that QHPs meet these minimum requirements as described in the Exchange rule under 45 CFR parts 155 and 156, based on the Affordable Care Act, as well as other requirements determined by the Exchange. In [[Page 72067]] addition to data collection for the certification of QHPs, the reinsurance and risk adjustment programs outlined by the Affordable Care Act, detailed in 45 CFR part 153, as established by CMS-9975-F, Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk Corridors, and Risk Adjustment (77 FR 17220), published in March 23, 2012, have general information reporting requirements that apply to issuers, group health plans, third party administrators, and plan offerings outside of the Exchanges. Subsequent regulations for these programs including the final HHS Notice of Benefit and Payment Parameters for 2014 and the Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 provide further reporting requirements. Form Number: CMS-10433 (OMB Control Number 0938-1187); Frequency: Annually; Affected Public: States and Private Sector; Number of Respondents: 26,951; Number of Responses: 26,951; Total Annual Hours: 235,153. (For questions regarding this collection contact Leigha Basini at 301-492-4380.) Dated: November 12, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-29343 Filed 11-17-15; 8:45 am] BILLING CODE 4120-01-P
![72066 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of Average
Total burden Total cost
Form name respondents/ hourly wage
hours burden
POCs rate*
Total .......................................................................................................... 280 454 NA $18,613
* National Compensation Survey: Occupational wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a) and c) Based on the mean hourly wages for Computer Programmer (15–1131). b) Based on the mean hourly wage for Chief Executives (11–
1011). http://www.bls.gov/oes/current/oes_nat.htm#15–0000.
Request for Comments information, including each proposed must obtain approval from the Office of
In accordance with the Paperwork extension or reinstatement of an existing Management and Budget (OMB) for each
Reduction Act, comments on AHRQ’s collection of information, and to allow collection of information they conduct
information collection are requested a second opportunity for public or sponsor. The term ‘‘collection of
with regard to any of the following: (a) comment on the notice. Interested information’’ is defined in 44 U.S.C.
Whether the proposed collection of persons are invited to send comments 3502(3) and 5 CFR 1320.3(c) and
information is necessary for the proper regarding the burden estimate or any includes agency requests or
performance of AHRQ health care other aspect of this collection of requirements that members of the public
research and information dissemination information, including any of the submit reports, keep records, or provide
functions, including whether the following subjects: (1) The necessity and information to a third party. Section
information will have practical utility; utility of the proposed information 3506(c)(2)(A) of the PRA (44 U.S.C.
(b) the accuracy of AHRQ’s estimate of collection for the proper performance of 3506(c)(2)(A)) requires federal agencies
burden (including hours and costs) of the agency’s functions; (2) the accuracy to publish a 30-day notice in the
the proposed collection(s) of of the estimated burden; (3) ways to Federal Register concerning each
information; (c) ways to enhance the enhance the quality, utility, and clarity proposed collection of information,
quality, utility, and clarity of the of the information to be collected; and including each proposed extension or
information to be collected; and (d) (4) the use of automated collection reinstatement of an existing collection
ways to minimize the burden of the techniques or other forms of information of information, before submitting the
collection of information upon the technology to minimize the information collection to OMB for approval. To
respondents, including the use of collection burden. comply with this requirement, CMS is
automated collection techniques or DATES: Comments on the collection(s) of publishing this notice that summarizes
other forms of information technology. information must be received by the the following proposed collection(s) of
Comments submitted in response to OMB desk officer by December 18, 2015: information for public comment:
this notice will be summarized and ADDRESSES: When commenting on the 1. Type of Information Collection
included in the Agency’s subsequent proposed information collections, Request: Revision of a currently
request for OMB approval of the please reference the document identifier approved information collection; Title
proposed information collection. All or OMB control number. To be assured of Information Collection: Initial Plan
comments will become a matter of consideration, comments and Data Collection to Support Qualified
public record. recommendations must be received by Health Plan (QHP) Certification and
the OMB desk officer via one of the Other Financial Management and
Sharon B. Arnold, Exchange Operations; Use: As required
following transmissions:
Deputy Director. by the CMS–9989–F, Patient Protection
OMB, Office of Information and
[FR Doc. 2015–29440 Filed 11–17–15; 8:45 am] Regulatory Affairs and Affordable Care Act; Establishment
BILLING CODE 4160–90–P Attention: CMS Desk Officer of Exchanges and Qualified Health
Fax Number: (202) 395–5806 OR Plans; Exchange Standards for
Email: OIRA_submission@ Employers (77 FR 18310) (Exchange
DEPARTMENT OF HEALTH AND omb.eop.gov Establishment Rule), published on
HUMAN SERVICES To obtain copies of a supporting March 27, 2012, each Exchange must
statement and any related forms for the assume responsibilities related to the
Centers for Medicare & Medicaid proposed collection(s) summarized in certification and offering of Qualified
Services this notice, you may make your request Health Plans (QHPs). To offer insurance
[Document Identifiers: CMS–10433] using one of following: through an Exchange, a health insurance
1. Access CMS’ Web site address at issuer must have its health plans
Agency Information Collection http://www.cms.hhs.gov/ certified as QHPs by the Exchange.
Activities: Submission for OMB PaperworkReductionActof1995. A QHP must meet certain minimum
Review; Comment Request 2. Email your request, including your certification standards, such as those
address, phone number, OMB number, pertaining to essential community
ACTION: Notice. and CMS document identifier, to providers, essential health benefits, and
SUMMARY: The Centers for Medicare & Paperwork@cms.hhs.gov. actuarial value. In order to meet those
asabaliauskas on DSK5VPTVN1PROD with NOTICES
3. Call the Reports Clearance Office at
Medicaid Services (CMS) is announcing standards, the Exchange is responsible
(410) 786–1326.
an opportunity for the public to for collecting data and validating that
comment on CMS’ intention to collect FOR FURTHER INFORMATION CONTACT: QHPs meet these minimum
information from the public. Under the Reports Clearance Office at (410) 786– requirements as described in the
Paperwork Reduction Act of 1995 1326. Exchange rule under 45 CFR parts 155
(PRA), federal agencies are required to SUPPLEMENTARY INFORMATION: Under the and 156, based on the Affordable Care
publish notice in the Federal Register Paperwork Reduction Act of 1995 (PRA) Act, as well as other requirements
concerning each proposed collection of (44 U.S.C. 3501–3520), federal agencies determined by the Exchange. In
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![Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices 72067
addition to data collection for the Agency’s Division of Dockets Submissions,’’ publicly viewable at
certification of QHPs, the reinsurance Management. http://www.regulations.gov or at the
and risk adjustment programs outlined ADDRESSES: You may submit comments Division of Dockets Management
by the Affordable Care Act, detailed in as follows: between 9 a.m. and 4 p.m., Monday
45 CFR part 153, as established by through Friday.
CMS–9975–F, Patient Protection and Electronic Submissions • Confidential Submissions—To
Affordable Care Act; Standards for Submit electronic comments in the submit a comment with confidential
Reinsurance, Risk Corridors, and Risk following way: information that you do not wish to be
Adjustment (77 FR 17220), published in • Federal eRulemaking Portal: http:// made publicly available, submit your
March 23, 2012, have general www.regulations.gov. Follow the comments only as a written/paper
information reporting requirements that instructions for submitting comments. submission. You should submit two
apply to issuers, group health plans, Comments submitted electronically, copies total. One copy will include the
third party administrators, and plan including attachments, to http:// information you claim to be confidential
offerings outside of the Exchanges. www.regulations.gov will be posted to with a heading or cover note that states
Subsequent regulations for these the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
programs including the final HHS comment will be made public, you are CONFIDENTIAL INFORMATION’’. The
Notice of Benefit and Payment solely responsible for ensuring that your Agency will review this copy, including
Parameters for 2014 and the Program comment does not include any the claimed confidential information, in
Integrity: Exchange, Premium confidential information that you or a its consideration of comments. The
Stabilization Programs, and Market third party may not wish to be posted, second copy, which will have the
Standards; Amendments to the HHS such as medical information, your or claimed confidential information
Notice of Benefit and Payment anyone else’s Social Security number, or redacted/blacked out, will be available
Parameters for 2014 provide further confidential business information, such for public viewing and posted on
reporting requirements. Form Number: as a manufacturing process. Please note http://www.regulations.gov. Submit
CMS–10433 (OMB Control Number that if you include your name, contact both copies to the Division of Dockets
0938–1187); Frequency: Annually; information, or other information that Management. If you do not wish your
Affected Public: States and Private identifies you in the body of your name and contact information to be
Sector; Number of Respondents: 26,951; comments, that information will be made publicly available, you can
Number of Responses: 26,951; Total posted on http://www.regulations.gov. provide this information on the cover
Annual Hours: 235,153. (For questions • If you want to submit a comment sheet and not in the body of your
regarding this collection contact Leigha with confidential information that you comments and you must identify this
Basini at 301–492–4380.) do not wish to be made available to the information as ‘‘confidential.’’ Any
Dated: November 12, 2015. public, submit the comment as a information marked as ‘‘confidential’’
William N. Parham, III, written/paper submission and in the will not be disclosed except in
manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
Affairs. information about FDA’s posting of
Written/Paper Submissions comments to public dockets, see 80 FR
[FR Doc. 2015–29343 Filed 11–17–15; 8:45 am]
Submit written/paper submissions as 56469, September 18, 2015, or access
BILLING CODE 4120–01–P
follows: the information at: http://www.fda.gov/
• Mail/Hand delivery/Courier (for regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND written/paper submissions): Division of default.htm.
HUMAN SERVICES Dockets Management (HFA–305), Food Docket: For access to the docket to
and Drug Administration, 5630 Fishers read background documents or the
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
• For written/paper comments received, go to http://
[Docket Nos. FDA–2015–M–1707, FDA– www.regulations.gov and insert the
2015–M–2218, FDA–2015–M–2217, FDA– submitted to the Division of Dockets
2015–M–2497, FDA–2015–M–2219, FDA– Management, FDA will post your docket number, found in brackets in the
2015–M–2499, FDA–2015–M–2634, FDA– comment, as well as any attachments, heading of this document, into the
2015–M–2584, FDA–2015–M–2618, FDA– except for information submitted, ‘‘Search’’ box and follow the prompts
2015–M–2739, FDA–2015–M–2740, and marked and identified, as confidential, and/or go to the Division of Dockets
FDA–2015–M–2964] if submitted as detailed in Management, 5630 Fishers Lane, Rm.
‘‘Instructions.’’ 1061, Rockville, MD 20852.
Medical Devices; Availability of Safety Instructions: All submissions received FOR FURTHER INFORMATION CONTACT:
and Effectiveness Summaries for must include the Docket Nos. FDA– Melissa Torres, Center for Devices and
Premarket Approval Applications 2015–M–1707, FDA–2015–M–2218, Radiological Health, Food and Drug
AGENCY: Food and Drug Administration, FDA–2015–M–2217, FDA–2015–M– Administration, 10903 New Hampshire
HHS. 2497, FDA–2015–M–2219, FDA–2015– Ave., Bldg. 66, Rm. 1650, Silver Spring,
ACTION: Notice. M–2499, FDA–2015–M–2634, FDA– MD 20993–0002, 301–796–5576.
2015–M–2584, FDA–2015–M–2618,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug FDA–2015–M–2739, FDA–2015–M–
Administration (FDA) is publishing a 2740, and FDA–2015–M–2964 for I. Background
list of premarket approval applications ‘‘Medical Devices; Availability of Safety In accordance with sections 515(d)(4)
(PMAs) that have been approved. This and Effectiveness Summaries for and (e)(2) of the Federal Food, Drug, and
list is intended to inform the public of Premarket Approval Applications.’’ Cosmetic Act (the FD&C Act) (21 U.S.C.
the availability of safety and Received comments will be placed in 360e(d)(4) and (e)(2)), notification of an
effectiveness summaries of approved the docket and, except for those order approving, denying, or
PMAs through the Internet and the submitted as ‘‘Confidential withdrawing approval of a PMA will
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Document Created: 2018-03-01 11:20:33
Document Modified: 2018-03-01 11:20:33
| 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 December 18, 2015: | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 72066 |
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