82 FR 61762 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 249 (December 29, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 249 (December 29, 2017)
| Page Range | 61762-61763 | |
| FR Document | 2017-28159 |
[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)] [Notices] [Pages 61762-61763] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28159] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-262] Agency Information Collection Activities: Submission for OMB Review; 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 (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 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 January 29, 2018. 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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 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: William Parham at (410) 786-4669. 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: Contract Year 2019 Plan Benefit Package (PBP) Software and Formulary Submission; Use: We require that Medicare [[Page 61763]] Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. This notice replaces the 30-day Federal Register notice that published on December 13, 2017 (82 FR 58613) which was subsequently withdrawn on December 22, 2017 (82 FR 60744). Form Number: CMS-R-262 (OMB control number 0938-0763); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 520; Total Annual Responses: 5,675; Total Annual Hours: 56,450. (For policy questions regarding this collection contact Kristy Holtje at 410-786- 2209.) Dated: December 26, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-28159 Filed 12-28-17; 8:45 am] BILLING CODE 4120-01-P
![61762 Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices
Bard’s tunneled home drainage catheter Agreement and to keep the Commission minimize the information collection
systems business and BD’s soft tissue informed about the status of the transfer burden.
core needle biopsy devices business to of assets to Merit. The Commission has DATES: Comments on the collection(s) of
Merit. The provisions of the Consent appointed Mazars LLP as the Monitor in information must be received by the
Agreement will enable Merit to become this matter. The proposed Order further OMB desk officer by January 29, 2018.
an independent, viable, and effective allows the Commission to appoint a ADDRESSES: When commenting on the
competitor in the respective relevant trustee in the event the parties fail to proposed information collections,
markets and maintain the competition divest the products as required. please reference the document identifier
that currently exists.
VII. Opportunity for Public Comment or OMB control number. To be assured
Merit, headquartered in South Jordan,
consideration, comments and
Utah, is a global company with 30 years The purpose of this analysis is to
recommendations must be received by
of experience in the development, facilitate public comment on the
manufacture, and distribution of the OMB desk officer via one of the
Consent Agreement to aid the
medical devices used in interventional, following transmissions: OMB, Office of
Commission in determining whether it
diagnostic, and therapeutic procedures. Information and Regulatory Affairs,
should make the Order final. This
Merit offers a portfolio of products that Attention: CMS Desk Officer, Fax
analysis is not intended to constitute an
is highly complementary to the Number: (202) 395–5806 OR, Email:
official interpretation of the proposed
tunneled home drainage catheter OIRA_submission@omb.eop.gov.
Consent Agreement and does not To obtain copies of a supporting
systems being acquired. Merit also modify its terms in any way. statement and any related forms for the
recently introduced its first soft tissue
By direction of the Commission. proposed collection(s) summarized in
core needle biopsy device product.
Merit possesses substantial industry April J. Tabor, this notice, you may make your request
expertise in these product areas and Acting Secretary. using one of following:
[FR Doc. 2017–28213 Filed 12–28–17; 8:45 am] 1. Access CMS’ website address at
sells its products to similar customers as
https://www.cms.gov/Regulations-and-
BD and Bard. For these reasons, Merit BILLING CODE 6750–01–P
Guidance/Legislation/
is well positioned to restore the benefits
PaperworkReductionActof1995/PRA-
of competition that would be lost due to
Listing.html.
the Acquisition.
DEPARTMENT OF HEALTH AND 2. Email your request, including your
Pursuant to the Order, Merit will
HUMAN SERVICES address, phone number, OMB number,
receive all rights and assets related to
Bard’s tunneled home drainage catheter and CMS document identifier, to
Centers for Medicare & Medicaid Paperwork@cms.hhs.gov.
system business and BD’s soft tissue Services 3. Call the Reports Clearance Office at
core needle biopsy device business,
(410) 786–1326.
including all of the confidential [Document Identifier: CMS–R–262]
business information used in those FOR FURTHER INFORMATION CONTACT:
businesses. Merit will own or receive a William Parham at (410) 786–4669.
Agency Information Collection
license to all intellectual property SUPPLEMENTARY INFORMATION: Under the
Activities: Submission for OMB
necessary to run the businesses. It will Review; Comment Request Paperwork Reduction Act of 1995 (PRA)
also acquire the equipment used in the (44 U.S.C. 3501–3520), federal agencies
manufacturing of the products and all AGENCY: Centers for Medicare & must obtain approval from the Office of
documentation and other information Medicaid Services, HHS. Management and Budget (OMB) for each
related to the products. Respondents ACTION: Notice. collection of information they conduct
will also contract manufacture products or sponsor. The term ‘‘collection of
for Merit until it is able to manufacture SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
them itself, and Respondents will Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
provide transitional services to Merit to an opportunity for the public to includes agency requests or
assist the company in establishing comment on CMS’ intention to collect requirements that members of the public
manufacturing capabilities for the information from the public. Under the submit reports, keep records, or provide
divested products. Paperwork Reduction Act of 1995 information to a third party. Section
The Respondents must accomplish (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
the divestitures no later than 10 days publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
after the consummation of the proposed concerning each proposed collection of to publish a 30-day notice in the
Acquisition. If the Commission information, including each proposed Federal Register concerning each
determines that Merit is not an extension or reinstatement of an existing proposed collection of information,
acceptable acquirer, or that the manner collection of information, and to allow including each proposed extension or
of the divestitures is not acceptable, the a second opportunity for public reinstatement of an existing collection
proposed Order requires the comment on the notice. Interested of information, before submitting the
Respondents to unwind the sale of persons are invited to send comments collection to OMB for approval. To
assets to Merit and then divest the assets regarding the burden estimate or any comply with this requirement, CMS is
to a Commission-approved acquirer(s) other aspect of this collection of publishing this notice that summarizes
within 180 days of the date the Order information, including the necessity and the following proposed collection(s) of
becomes final. Pursuant to the Order To utility of the proposed information information for public comment:
ethrower on DSK3G9T082PROD with NOTICES
Maintain Assets, Respondents must collection for the proper performance of 1. Type of Information Collection
maintain the businesses pending the agency’s functions, the accuracy of Request: Revision of a currently
divestiture. the estimated burden, ways to enhance approved collection; Title of
The Commission has agreed to the quality, utility, and clarity of the Information Collection: Contract Year
appoint a Monitor to ensure that the information to be collected; and the use 2019 Plan Benefit Package (PBP)
Respondents comply with all of their of automated collection techniques or Software and Formulary Submission;
obligations pursuant to the Consent other forms of information technology to Use: We require that Medicare
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![Federal Register / Vol. 82, No. 249 / Friday, December 29, 2017 / Notices 61763
Advantage and Prescription Drug Plan products (hereafter referred to as 2017–D–6530 for ‘‘Formal Meetings
organizations submit a completed PBP products). The previous guidance for Between the Food and Drug
and formulary as part of the annual industry ‘‘Formal Meetings Between the Administration and Sponsors or
bidding process. During this process, FDA and Sponsors or Applicants’’ Applicants of Prescription Drug User
organizations prepare their proposed published May 19, 2009, and the draft Fee Act Products; Draft Guidance for
plan benefit packages for the upcoming guidance for industry ‘‘Formal Meetings Industry; Availability.’’ Received
contract year and submit them to us for Between the FDA and Sponsors or comments will be placed in the docket
review and approval. We publish Applicants of PDUFA Products’’ and, except for those submitted as
beneficiary education information using published March 11, 2015, have been ‘‘Confidential Submissions,’’ publicly
a variety of formats. The specific withdrawn. viewable at https://www.regulations.gov
education initiatives that utilize PBP or at the Dockets Management Staff
DATES: Submit either electronic or
and formulary data include web between 9 a.m. and 4 p.m., Monday
written comments on the draft guidance
application tools on www.medicare.gov through Friday.
by March 29, 2018 to ensure that the • Confidential Submissions—To
and the plan benefit insert in the
Agency considers your comment on this submit a comment with confidential
Medicare & You handbook. In addition,
draft guidance before it begins work on information that you do not wish to be
organizations utilize the PBP data to
the final version of the guidance. made publicly available, submit your
generate their Summary of Benefits
marketing information. ADDRESSES: You may submit comments comments only as a written/paper
This notice replaces the 30-day on any guidance at any time as follows: submission. You should submit two
Federal Register notice that published Electronic Submissions copies total. One copy will include the
on December 13, 2017 (82 FR 58613) information you claim to be confidential
which was subsequently withdrawn on Submit electronic comments in the with a heading or cover note that states
December 22, 2017 (82 FR 60744). following way: ‘‘THIS DOCUMENT CONTAINS
Form Number: CMS–R–262 (OMB • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
control number 0938–0763); Frequency: https://www.regulations.gov. Follow the Agency will review this copy, including
Yearly; Affected Public: Private sector instructions for submitting comments. the claimed confidential information, in
(Business or other for-profits and Not- Comments submitted electronically, its consideration of comments. The
for-profit institutions); Number of including attachments, to https:// second copy, which will have the
Respondents: 520; Total Annual www.regulations.gov will be posted to claimed confidential information
Responses: 5,675; Total Annual Hours: the docket unchanged. Because your redacted/blacked out, will be available
56,450. (For policy questions regarding comment will be made public, you are for public viewing and posted on
this collection contact Kristy Holtje at solely responsible for ensuring that your https://www.regulations.gov. Submit
410–786–2209.) comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Dated: December 26, 2017.
third party may not wish to be posted, contact information to be made publicly
William N. Parham, III, such as medical information, your or available, you can provide this
Director, Paperwork Reduction Staff, Office anyone else’s Social Security number, or information on the cover sheet and not
of Strategic Operations and Regulatory confidential business information, such
Affairs. in the body of your comments and you
as a manufacturing process. Please note must identify this information as
[FR Doc. 2017–28159 Filed 12–28–17; 8:45 am]
that if you include your name, contact ‘‘confidential.’’ Any information marked
BILLING CODE 4120–01–P information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
comments, that information will be and other applicable disclosure law. For
DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. more information about FDA’s posting
HUMAN SERVICES • If you want to submit a comment of comments to public dockets, see 80
Food and Drug Administration with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
[Docket No. FDA–2017–D–6530] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
Formal Meetings Between the Food manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
and Drug Administration and Sponsors Submissions’’ and ‘‘Instructions’’). read background documents or the
or Applicants of Prescription Drug electronic and written/paper comments
User Fee Act Products; Draft Guidance Written/Paper Submissions
received, go to https://
for Industry; Availability Submit written/paper submissions as www.regulations.gov and insert the
AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the
HHS. • Mail/Hand delivery/Courier (for heading of this document, into the
ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
announcing the availability of a draft • For written/paper comments You may submit comments on any
guidance for industry entitled ‘‘Formal submitted to the Dockets Management guidance at any time (see 21 CFR
ethrower on DSK3G9T082PROD with NOTICES
Meetings Between the FDA and Staff, FDA will post your comment, as 10.115(g)(5)).
Sponsors or Applicants of PDUFA well as any attachments, except for Submit written requests for single
Products.’’ This draft guidance provides information submitted, marked and copies of the draft guidance to the
recommendations to industry on formal identified, as confidential, if submitted Division of Drug Information, Center for
meetings between FDA and sponsors or as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
applicants relating to the development Instructions: All submissions received and Drug Administration, 10001 New
and review of drug or biological must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
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Document Created: 2018-01-03 13:16:39
Document Modified: 2018-01-03 13:16:39
| 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 January 29, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 61762 |
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