81 FR 91937 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 243 (December 19, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 243 (December 19, 2016)
| Page Range | 91937-91938 | |
| FR Document | 2016-30432 |
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)] [Notices] [Pages 91937-91938] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30432] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10171] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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 (the 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 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: 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 must be received by February 17, 2017. 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 http://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 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: 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-10171 Collecting Benefit Coordination Data 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. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Collecting Benefit Coordination Data; Use: This collection of information request coordinates Part D plan prescription drug coverage with other prescription drug coverage. The collected information will assist CMS, Part D [[Page 91938]] plans and other payers with coordination of prescription drug benefits at the point-of-sale and tracking of the beneficiary's True out-of- pocket (TrOOP) expenditures using the Part D Transaction Facilitator (PDTF). Form Number: CMS-10171 (OMB control number: 0938-0978); Frequency: Yearly and occasionally; Affected Public: Business or other for-profits; Number of Respondents: 62,438; Total Annual Responses: 891,777,634; Total Annual Hours: 5,201,718. (For policy questions regarding this collection contact Shelly Winston at 410-786-3694.) 2. Dated: December 14, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-30432 Filed 12-16-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices 91937
perceptions, and attitudes across information collection will guide the reduction in binge drinking, which will
various audience segments: those who CDC Alcohol Program in the in turn reduce alcohol-related injuries
engage in binge drinking, those who development and refinement of targeted and deaths among adults.
drink but not excessively, and those messages to effectively communicate the OMB approval is requested for one
who abstain from drinking. problem of excessive alcohol use, and year. Participation is voluntary and
The focus group discussions will be encourage support for effective
analyzed using qualitative tools and there are no costs to respondents other
prevention strategies. The ultimate goal than their time. The total estimated
leverage a structured approach to of the subsequent messaging is a
thematic analysis. Findings from this annual burden hours are 132.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Adults aged 21–64 .......................................... Questionnaire/Screener ................................. 288 1 5/60
Focus Group .................................................. 72 1 1.5
Total ......................................................... ......................................................................... ........................ ........................ ........................
Leroy A. Richardson, clarity of the information to be SUPPLEMENTARY INFORMATION:
Chief, Information Collection Review Office, collected; and the use of automated
Office of Scientific Integrity, Office of the Contents
collection techniques or other forms of
Associate Director for Science, Office of the information technology to minimize the This notice sets out a summary of the
Director, Centers for Disease Control and information collection burden. use and burden associated with the
Prevention. following information collections. More
DATES: Comments must be received by
[FR Doc. 2016–30400 Filed 12–16–16; 8:45 am] detailed information can be found in
February 17, 2017.
BILLING CODE 4163–18–P
ADDRESSES: When commenting, please each collection’s supporting statement
reference the document identifier or and associated materials (see
OMB control number. To be assured ADDRESSES).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES consideration, comments and CMS–10171 Collecting Benefit
recommendations must be submitted in Coordination Data
Centers for Medicare & Medicaid any one of the following ways:
1. Electronically. You may send your Under the PRA (44 U.S.C. 3501–
Services 3520), federal agencies must obtain
comments electronically to http://
[Document Identifier: CMS–10171] www.regulations.gov. Follow the approval from the Office of Management
instructions for ‘‘Comment or and Budget (OMB) for each collection of
Agency Information Collection information they conduct or sponsor.
Submission’’ or ‘‘More Search Options’’
Activities: Proposed Collection; The term ‘‘collection of information’’ is
to find the information collection
Comment Request defined in 44 U.S.C. 3502(3) and 5 CFR
document(s) that are accepting
AGENCY: Centers for Medicare & comments. 1320.3(c) and includes agency requests
Medicaid Services, HHS. 2. By regular mail. You may mail or requirements that members of the
ACTION: Notice. written comments to the following public submit reports, keep records, or
address: CMS, Office of Strategic provide information to a third party.
SUMMARY: The Centers for Medicare & Operations and Regulatory Affairs, Section 3506(c)(2)(A) of the PRA
Medicaid Services (CMS) is announcing Division of Regulations Development, requires federal agencies to publish a
an opportunity for the public to Attention: Document Identifier/OMB 60-day notice in the Federal Register
comment on CMS’ intention to collect Control Number ___, Room C4–26–05, concerning each proposed collection of
information from the public. Under the 7500 Security Boulevard, Baltimore, information, including each proposed
Paperwork Reduction Act of 1995 (the Maryland 21244–1850. extension or reinstatement of an existing
PRA), federal agencies are required to To obtain copies of a supporting collection of information, before
publish notice in the Federal Register statement and any related forms for the submitting the collection to OMB for
concerning each proposed collection of proposed collection(s) summarized in approval. To comply with this
information (including each proposed this notice, you may make your request requirement, CMS is publishing this
extension or reinstatement of an existing using one of following: notice.
collection of information) and to allow 1. Access CMS’ Web site address at
60 days for public comment on the http://www.cms.hhs.gov/Paperwork Information Collection
proposed action. Interested persons are ReductionActof1995. 1. Type of Information Collection
invited to send comments regarding our 2. Email your request, including your Request: Extension of a currently
address, phone number, OMB number, approved collection; Title of
sradovich on DSK3GMQ082PROD with NOTICES
burden estimates or any other aspect of
this collection of information, including and CMS document identifier, to Information Collection: Collecting
any of the following subjects: the Paperwork@cms.hhs.gov. Benefit Coordination Data; Use: This
necessity and utility of the proposed 3. Call the Reports Clearance Office at collection of information request
information collection for the proper (410) 786–1326. coordinates Part D plan prescription
performance of the agency’s functions; FOR FURTHER INFORMATION CONTACT: drug coverage with other prescription
the accuracy of the estimated burden; Reports Clearance Office at (410) 786– drug coverage. The collected
ways to enhance the quality, utility, and 1326. information will assist CMS, Part D
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![91938 Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices
plans and other payers with Electronic Submissions information you claim to be confidential
coordination of prescription drug Submit electronic comments in the with a heading or cover note that states
benefits at the point-of-sale and tracking following way: ‘‘THIS DOCUMENT CONTAINS
of the beneficiary’s True out-of-pocket • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
(TrOOP) expenditures using the Part D https://www.regulations.gov. Follow the Agency will review this copy, including
Transaction Facilitator (PDTF). Form instructions for submitting comments. the claimed confidential information, in
Number: CMS–10171 (OMB control Comments submitted electronically, its consideration of comments. The
number: 0938–0978); Frequency: Yearly including attachments, to https:// second copy, which will have the
and occasionally; Affected Public: www.regulations.gov will be posted to claimed confidential information
Business or other for-profits; Number of the docket unchanged. Because your redacted/blacked out, will be available
Respondents: 62,438; Total Annual comment will be made public, you are for public viewing and posted on
Responses: 891,777,634; Total Annual solely responsible for ensuring that your https://www.regulations.gov. Submit
Hours: 5,201,718. (For policy questions comment does not include any both copies to the Division of Dockets
regarding this collection contact Shelly confidential information that you or a Management. If you do not wish your
Winston at 410–786–3694.) third party may not wish to be posted, name and contact information to be
2. such as medical information, your or made publicly available, you can
Dated: December 14, 2016. anyone else’s Social Security number, or provide this information on the cover
William N. Parham, III, confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory that if you include your name, contact information as ‘‘confidential.’’ Any
Affairs. information, or other information that information marked as ‘‘confidential’’
[FR Doc. 2016–30432 Filed 12–16–16; 8:45 am] identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
BILLING CODE 4120–01–P
posted on https://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
DEPARTMENT OF HEALTH AND with confidential information that you comments to public dockets, see 80 FR
HUMAN SERVICES do not wish to be made available to the 56469, September 18, 2015, or access
public, submit the comment as a the information at: http://www.fda.gov/
Food and Drug Administration written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
[Docket No. FDA–2015–E–3157]
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Determination of Regulatory Review read background documents or the
Written/Paper Submissions electronic and written/paper comments
Period for Purposes of Patent
Extension; TRULICITY Submit written/paper submissions as received, go to https://
follows: www.regulations.gov and insert the
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for docket number, found in brackets in the
HHS. written/paper submissions): Division of heading of this document, into the
ACTION: Notice. Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
Administration (FDA) has determined • For written/paper comments 1061, Rockville, MD 20852.
the regulatory review period for submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
TRULICITY and is publishing this Management, FDA will post your Beverly Friedman, Office of Regulatory
notice of that determination as required comment, as well as any attachments, Policy, Food and Drug Administration,
by law. FDA has made the except for information submitted, 10903 New Hampshire Ave., Bldg. 51,
determination because of the marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993,
submission of an application to the if submitted as detailed in 301–796–3600.
Director of the U.S. Patent and ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
Trademark Office (USPTO), Department Instructions: All submissions received
of Commerce, for the extension of a must include the Docket No. FDA– I. Background
patent which claims that human 2015–E–3157 for ‘‘Determination of The Drug Price Competition and
biological product. Regulatory Review Period for Purposes Patent Term Restoration Act of 1984
DATES: Anyone with knowledge that any of Patent Extension; TRULICITY.’’ (Pub. L. 98–417) and the Generic
of the dates as published (see the Received comments will be placed in Animal Drug and Patent Term
SUPPLEMENTARY INFORMATION section) are the docket and, except for those Restoration Act (Pub. L. 100–670)
incorrect may submit either electronic submitted as ‘‘Confidential generally provide that a patent may be
or written comments and ask for a Submissions,’’ publicly viewable at extended for a period of up to 5 years
redetermination by February 17, 2017. https://www.regulations.gov or at the so long as the patented item (human
Furthermore, any interested person may Division of Dockets Management drug product, animal drug product,
petition FDA for a determination between 9 a.m. and 4 p.m., Monday medical device, food additive, or color
regarding whether the applicant for through Friday. additive) was subject to regulatory
sradovich on DSK3GMQ082PROD with NOTICES
extension acted with due diligence • Confidential Submissions—To review by FDA before the item was
during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s
June 19, 2017. See ‘‘Petitions’’ in the information that you do not wish to be regulatory review period forms the basis
SUPPLEMENTARY INFORMATION section for made publicly available, submit your for determining the amount of extension
more information. comments only as a written/paper an applicant may receive.
ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of
as follows: June 19, 2017 copies total. One copy will include the two periods of time: A testing phase and
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Document Created: 2016-12-17 03:15:54
Document Modified: 2016-12-17 03:15:54
| 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 must be received by February 17, 2017. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 91937 |
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