Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 77497 

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: Bid Pricing Tool 

(BPT) for Medicare Advantage (MA) 

Plans and Prescription Drug Plans 

(PDP); Use: We require that Medicare 

Advantage organizations and 

Prescription Drug Plans complete the 

Bid Pricing Tool (BPT) as part of the 

annual bidding process. During this 

process, organizations prepare their 

proposed actuarial bid pricing for the 

upcoming contract year and submit 

them to us for review and approval. The 

purpose of the BPT is to collect the 

actuarial pricing information for each 

plan. The BPT calculates the plan’s bid, 

enrollee premiums, and payment rates. 

We publish beneficiary premium 

information using a variety of formats 

(www.medicare.gov, the Medicare & You 

handbook, Summary of Benefits 

marketing information) for the purpose 

of beneficiary education and 

enrollment. Form Number: CMS–10142 

(OMB control number 0938–0944); 

Frequency: Yearly; Affected Public: 

Private sector (Business or other forprofits and Not-for-profit institutions); 

Number of Respondents: 555; Total 

Annual Responses: 4,995; Total Annual 

Hours: 149,850. (For policy questions 

regarding this collection contact Rachel 

Shevland at 410–786–3026). 

Dated: December 18, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–30026 Filed 12–23–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–1557] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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: (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 must be received by 

February 23, 2015. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). 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 Numberll, 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/Paperwork

ReductionActof1995. 

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. 

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–1557 Survey Report Form for 

Clinical Laboratory Improvement 

Amendments (CLIA) and Supporting 

Regulations 

Under the Paperwork Reduction Act 

(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: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations. Use: The form 

is used to report surveyor findings 

during a CLIA survey. For each type of 

survey conducted (i.e., initial 

certification, recertification, validation, 

complaint, addition/deletion of 

specialty/subspecialty, transfusion 

fatality investigation, or revisit 

inspections) the Survey Report Form 

incorporates the requirements specified 

in the CLIA regulations. Form Number: 

CMS–1557 (OMB control number: 

0938–0544). Frequency: Biennially. 

Affected Public: Business or other forprofit, not-for-profit institutions, State, 

Local or Tribal Governments and 

Federal Government. Number of 

Respondents: 19,051. Total Annual 

Responses: 9,526. Total Annual Hours: 

4,763. (For policy questions regarding 

this collection contact Kathleen Todd at 

410–786–3385). 

mstockstill on DSK4VPTVN1PROD with NOTICES

77498 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Notices 

Dated: December 18, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–30027 Filed 12–23–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1461] 

Rare Pediatric Disease Priority Review 

Vouchers; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for the notice of 

availability (NOA) that appeared in the 

Federal Register of November 17, 2014. 

In the NOA, FDA requested comments 

on the Agency’s implementation of the 

Rare Pediatric Disease Priority Review 

Vouchers Program. This action will 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the NOA published November 

17, 2014 (79 FR 68451). Submit either 

electronic or written comments by 

February 16, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communications, Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002; or Office 

of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002; or Office 

of Orphan Products Development, 

Office of Special Medical Programs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

5295, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist the office that will be 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Henry Startzman III, Office of Orphan 

Products Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5295, Silver Spring, 

MD 20993–0002, 301–796–8660. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

17, 2014, FDA published a NOA with a 

60-day comment period to request 

comments on FDA’s implementation of 

the Rare Pediatric Disease Priority 

Review Vouchers Draft Guidance. 

Comments on the draft guidance will 

inform FDA’s drafting of its final 

guidance for this program. 

The Agency has recognized a 

discrepancy between the 90-day 

comment period included in the draft 

guidance and the 60-day comment 

period written in the November 17, 

2014, NOA. Thus, it is publishing this 

NOA to extend the comment period 

cited in the previous NOA by 30 days. 

The Agency believes that a 30-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying drafting 

of the final guidance on these important 

issues. 

II. Request for Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30154 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0155] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 23, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0363. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Veterinary Feed Directive—21 CFR 558 

(OMB Control Number 0910–0363)— 

(Extension) 

With the passage of the Animal Drug 

Availability Act of 1996 (Public Law 

104–250), Congress enacted legislation 

establishing a new class of restricted 

feed use drugs, VFD drugs, which may 

be distributed without involving State 

pharmacy laws. Although controls on 

the distribution and use of VFD drugs 

are similar to those for prescription 

drugs regulated under section 503(f) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 353(f)), the implementing 

VFD regulation (21 CFR 558.6) was 

tailored to the unique circumstances 

mstockstill on DSK4VPTVN1PROD with NOTICES