80 FR 60150 - 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 192 (October 5, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 192 (October 5, 2015)
| Page Range | 60150-60151 | |
| FR Document | 2015-25212 |
[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)] [Notices] [Pages 60150-60151] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25212] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10565] 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 November 4, 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: New collection (Request for a new OMB control number); Title of Information Collection: Off- cycle Submission of Summaries of Model of Care Changes; Use: All Medicare Advantage (MA) Special Needs Plans (SNPs) must be approved by the National Committee for Quality Assurance (NCQA). The SNPs must submit Models of Care (MOC) as a component of the Medicare Advantage application process. Approval is based [[Page 60151]] on NCQA's evaluation of SNPs using MOC scoring guidelines. Based on their scores, SNPs receive an approval for a period of 1-, 2-, or 3- years. We are developing an MOC off-cycle revision process so that SNPs can revise the MOC to modify its processes and strategies for providing care during their MOC approval period. We will require that SNPs submit summaries of their MOC revisions to CMS for NCQA evaluation when a SNP makes significant changes to its MOC as described in the annual Announcement of Medicare Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call letter for CY 2015 and CY2016. The NCQA will review the summary of changes to verify that the revisions are consistent with the acceptable, high quality standards as included in the original approved MOC. The package has been revised subsequent to the publication of the 60-day Federal Register notice (June 17, 2015; 80 FR 34647). Form Number: CMS-10565 (OMB control number 0938-New); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 313; Total Annual Responses: 421; Total Annual Hours: 2,400. (For policy questions regarding this collection contact Susan Radke at 410-786-4450). Dated: September 30, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-25212 Filed 10-2-15; 8:45 am] BILLING CODE 4120-01-P
![60150 Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
period, and in consultation with the ‘‘Influenza (Flu) Vaccine (Live, ADDRESSES: When commenting on the
Advisory Commission on Childhood Intranasal): What you need to know’’ proposed information collections,
Vaccines, appropriate health care (publication date August 7, 2015). please reference the document identifier
provider and parent organizations, and With publication of this notice, as of or OMB control number. To be assured
the Food and Drug Administration. The March 1, 2016, all health care providers consideration, comments and
law also requires that the information will be required to provide copies of recommendations must be received by
contained in the materials be based on these updated inactivated and live the OMB desk officer via one of the
available data and information, be attenuated influenza vaccine following transmissions: OMB, Office of
presented in understandable terms, and information materials prior to Information and Regulatory Affairs,
include: immunization in conformance with Attention: CMS Desk Officer, Fax
(1) A concise description of the HHS/CDC’s August 7, 2015 Instructions Number: (202) 395 –5806 or Email:
benefits of the vaccine, for the Use of Vaccine Information OIRA_submission@omb.eop.gov.
(2) A concise description of the risks Statements. Prior to that date, the To obtain copies of a supporting
associated with the vaccine, previous edition of these two VISs can statement and any related forms for the
(3) A statement of the availability of be used. proposed collection(s) summarized in
the National Vaccine Injury Dated: September 29, 2015. this notice, you may make your request
Compensation Program, and using one of following:
(4) Such other relevant information as Sandra Cashman,
Acting Director, Division of the Executive 1. Access CMS’ Web site address at
may be determined by the Secretary. http://www.cms.hhs.gov/
The vaccines initially covered under Secretariat, Office of the Chief of Staff,
Centers for Disease Control and Prevention. PaperworkReductionActof1995.
the National Vaccine Injury 2. Email your request, including your
Compensation Program were diphtheria, [FR Doc. 2015–25159 Filed 10–2–15; 8:45 am]
address, phone number, OMB number,
tetanus, pertussis, measles, mumps, BILLING CODE 4163–18–P
and CMS document identifier, to
rubella and poliomyelitis vaccines. Paperwork@cms.hhs.gov.
Since April 15, 1992, any health care 3. Call the Reports Clearance Office at
provider in the United States who DEPARTMENT OF HEALTH AND
HUMAN SERVICES (410) 786–1326.
intends to administer one of these
FOR FURTHER INFORMATION CONTACT:
covered vaccines is required to provide Centers for Medicare & Medicaid Reports Clearance Office at (410) 786–
copies of the relevant vaccine Services 1326.
information materials prior to
administration of any of these vaccines. [Document Identifier: CMS–10565] SUPPLEMENTARY INFORMATION: Under the
Since then, the following vaccines have Paperwork Reduction Act of 1995 (PRA)
been added to the National Vaccine Agency Information Collection (44 U.S.C. 3501–3520), federal agencies
Injury Compensation Program, requiring Activities: Submission for OMB must obtain approval from the Office of
use of vaccine information materials for Review; Comment Request Management and Budget (OMB) for each
them as well: Hepatitis B, Haemophilus ACTION: Notice. collection of information they conduct
influenzae type b (Hib), varicella or sponsor. The term ‘‘collection of
(chickenpox), pneumococcal conjugate, SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
rotavirus, hepatitis A, meningococcal, Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
human papillomavirus (HPV), and an opportunity for the public to includes agency requests or
seasonal influenza vaccines. comment on CMS’ intention to collect requirements that members of the public
Instructions for use of the vaccine information from the public. Under the submit reports, keep records, or provide
information materials are found on the Paperwork Reduction Act of 1995 information to a third party. Section
CDC Web site at: http://www.cdc.gov/ (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
vaccines/hcp/vis/index.html. publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
concerning each proposed collection of to publish a 30-day notice in the
Revised Vaccine Information Materials information, including each proposed Federal Register concerning each
The revised inactivated and live extension or reinstatement of an existing proposed collection of information,
attenuated influenza vaccine collection of information, and to allow including each proposed extension or
information materials referenced in this a second opportunity for public reinstatement of an existing collection
notice were developed in consultation comment on the notice. Interested of information, before submitting the
with the Advisory Commission on persons are invited to send comments collection to OMB for approval. To
Childhood Vaccines, the Food and Drug regarding the burden estimate or any comply with this requirement, CMS is
Administration, and parent and other aspect of this collection of publishing this notice that summarizes
healthcare provider organizations. information, including any of the the following proposed collection(s) of
Following consultation and review of following subjects: (1) The necessity and information for public comment:
comments submitted, the vaccine utility of the proposed information 1. Type of Information Collection
information materials covering collection for the proper performance of Request: New collection (Request for a
inactivated and live attenuated the agency’s functions; (2) the accuracy new OMB control number); Title of
influenza vaccine have been finalized of the estimated burden; (3) ways to Information Collection: Off-cycle
and are available to download from enhance the quality, utility, and clarity Submission of Summaries of Model of
of the information to be collected; and
mstockstill on DSK4VPTVN1PROD with NOTICES
http://www.cdc.gov/vaccines/hcp/vis/ Care Changes; Use: All Medicare
index.html or http:// (4) the use of automated collection Advantage (MA) Special Needs Plans
www.regulations.gov (see Docket techniques or other forms of information (SNPs) must be approved by the
Number CDC–2015–0016). The Vaccine technology to minimize the information National Committee for Quality
Information Statements (VIS), are: collection burden. Assurance (NCQA). The SNPs must
‘‘Influenza (Flu) Vaccine (Inactivated or DATES: Comments on the collection(s) of submit Models of Care (MOC) as a
Recombinant): What you need to know’’ information must be received by the component of the Medicare Advantage
(publication date August 7, 2015) and OMB desk officer by November 4, 2015. application process. Approval is based
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![Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices 60151
on NCQA’s evaluation of SNPs using considered in preparing a response from Convention on Narcotic Drugs;
MOC scoring guidelines. Based on their the United States to the World Health Ketamine; Phenazepam; Etizolam; 1-
scores, SNPs receive an approval for a Organization (WHO) regarding the abuse cyclohexyl-4-(1,2-diphenylethyl)-
period of 1-, 2-, or 3-years. We are liability and diversion of these drugs. piperazine (MT-45); N-(1-
developing an MOC off-cycle revision WHO will use this information to Phenethylpiperidin-4-yl)-N-
process so that SNPs can revise the consider whether to recommend that phenylacetamide (Acetylfentanyl); a-
MOC to modify its processes and certain international restrictions be Pyrrolidinovalerophenone (a-PVP); 4-
strategies for providing care during their placed on these drugs. This notice Fluoroamphetamine (4-FA); para-
MOC approval period. We will require requesting comments is required by the Methyl-4-methylaminorex (4,4’-DMAR);
that SNPs submit summaries of their Controlled Substances Act (the CSA). para-Methoxymethylamphetamine
MOC revisions to CMS for NCQA DATES: Submit either electronic or (PMMA); 2-(ethylamino)-2-(3-
evaluation when a SNP makes written comments by October 15, 2015. methoxyphenyl)-cyclohexanone
significant changes to its MOC as (Methoxetamine or MXE); Request for
ADDRESSES: You may submit comments
described in the annual Announcement Comments. Received comments will be
as follows:
of Medicare Capitation Rates and placed in the docket and, except for
Medicare Advantage and Part D Electronic Submissions those submitted as ‘‘Confidential
Payment Policies and Final Call letter Submissions,’’ publicly viewable at
Submit electronic comments in the
for CY 2015 and CY2016. The NCQA http://www.regulations.gov or at the
following way:
will review the summary of changes to Division of Dockets Management
• Federal eRulemaking Portal: http://
verify that the revisions are consistent between 9 a.m. and 4 p.m., Monday
www.regulations.gov. Follow the
with the acceptable, high quality through Friday.
instructions for submitting comments. • Confidential Submissions—To
standards as included in the original
Comments submitted electronically, submit a comment with confidential
approved MOC. The package has been
including attachments, to http:// information that you do not wish to be
revised subsequent to the publication of
www.regulations.gov will be posted to made publicly available, submit your
the 60-day Federal Register notice (June
the docket unchanged. Because your comments only as a written/paper
17, 2015; 80 FR 34647). Form Number:
CMS–10565 (OMB control number comment will be made public, you are submission. You should submit two
0938-New); Frequency: Occasionally; solely responsible for ensuring that your copies total. One copy will include the
Affected Public: Private sector (Business comment does not include any information you claim to be confidential
or other for-profits and Not-for-profit confidential information that you or a with a heading or cover note that states
institutions); Number of Respondents: third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
313; Total Annual Responses: 421; Total such as medical information, your or CONFIDENTIAL INFORMATION’’. The
Annual Hours: 2,400. (For policy anyone else’s Social Security number, or Agency will review this copy, including
questions regarding this collection confidential business information, such the claimed confidential information, in
contact Susan Radke at 410–786–4450). as a manufacturing process. Please note its consideration of comments. The
that if you include your name, contact second copy, which will have the
Dated: September 30, 2015. information, or other information that claimed confidential information
William N. Parham, III, identifies you in the body of your redacted/blacked out, will be available
Director, Paperwork Reduction Staff, Office comments, that information will be for public viewing and posted on http://
of Strategic Operations and Regulatory posted on http://www.regulations.gov.
Affairs.
www.regulations.gov. Submit both
• If you want to submit a comment copies to the Division of Dockets
[FR Doc. 2015–25212 Filed 10–2–15; 8:45 am] with confidential information that you Management. If you do not wish your
BILLING CODE 4120–01–P do not wish to be made available to the name and contact information to be
public, submit the comment as a made publicly available, you can
written/paper submission and in the provide this information on the cover
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper sheet and not in the body of your
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). comments and you must identify this
Food and Drug Administration Written/Paper Submissions information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
[Docket No. FDA–2015–N–0045] Submit written/paper submissions as will not be disclosed except in
follows: accordance with 21 CFR 10.20 and other
International Drug Scheduling; • Mail/Hand delivery/Courier (for applicable disclosure law. For more
Convention on Psychotropic written/paper submissions): Division of information about FDA’s posting of
Substances; Single Convention on Dockets Management (HFA–305), Food comments to public dockets, see 80 FR
Narcotic Drugs; Ketamine and Nine and Drug Administration, 5630 Fishers 56469, September 18, 2015, or access
Other Substances; Request for Lane, rm. 1061, Rockville, MD 20852. the information at: http://www.fda.gov/
Comments • For written/paper comments regulatoryinformation/dockets/
AGENCY: Food and Drug Administration, submitted to the Division of Dockets default.htm.
HHS. Management, FDA will post your Docket: For access to the docket to
ACTION: Notice. comment, as well as any attachments, read background documents or the
except for information submitted, electronic and written/paper comments
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY: The Food and Drug marked and identified, as confidential, received, go to http://
Administration (FDA) is requesting if submitted as detailed in www.regulations.gov and insert the
interested persons to submit comments ‘‘Instructions.’’ docket number, found in brackets in the
concerning abuse potential, actual Instructions: All submissions received heading of this document, into the
abuse, medical usefulness, trafficking, must include the Docket No. FDA– ‘‘Search’’ box and follow the prompts
and impact of scheduling changes on 2015–N–0045 for International Drug and/or go to the Division of Dockets
availability for medical use of 10 drug Scheduling; Convention on Management, 5630 Fishers Lane, rm.
substances. These comments will be Psychotropic Substances; Single 1061, Rockville, MD 20852.
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Document Created: 2015-12-15 08:52:48
Document Modified: 2015-12-15 08:52:48
| 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 November 4, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 60150 |
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