25596 Federal Register / Vol. 79, No. 86 / Monday, May 5, 2014 / Notices 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–10144 Filed 5–2–14; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Research to Prevent 

Prescription Drug Overdoses, Funding 

Opportunity Announcement CE14–002, 

initial review. 

SUMMARY: This document corrects a 

notice that was published in the Federal 

Register on April 17, 2014 (79 FR 

21759). The time and date should read 

as follows: 

TIME AND DATE: 12:00 p.m.–7:00 p.m., 

May 7, 2014 (Closed). 

FOR FURTHER INFORMATION CONTACT: Jane 

Suen, Dr. P.H., M.S., Scientific Review 

Officer, CDC, 4770 Buford Highway NE., 

Mailstop F63, Atlanta, Georgia 30341– 

3724, Telephone: (770) 488–4281, 

JSuen@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–10145 Filed 5–2–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10495] 

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 must be received by 

June 2, 2014. 

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 

CMS or the OMB desk officer via one of 

the following transmissions: 

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 llll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

3. OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–5806 or, 

Email: OIRA_submission@omb.eop.gov. 

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 

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: 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: Registration, 

Attestation, Dispute & Resolution, 

Assumptions Document and Data 

Retention Requirements for Open 

Payments; Use: Section 6002 of the 

Affordable Care Act added section 

1128G to the Social Security Act (Act), 

which requires applicable 

manufacturers and applicable group 

purchasing organizations (GPOs) of 

covered drugs, devices, biologicals, or 

medical supplies to report annually to 

CMS certain payments or other transfers 

of value to physicians and teaching 

hospitals, as well as, certain information 

regarding the ownership or investment 

interests held by physicians or their 

immediate family members in 

applicable manufacturers or applicable 

GPOs. 

Specifically, applicable manufacturers 

of covered drugs, devices, biologicals, 

and medical supplies are required to 

submit on an annual basis the 

information required in section 

1128G(a)(1) of the Act about certain 

payments or other transfers of value 

made to physicians and teaching 

hospitals (collectively called covered 

recipients) during the course of the 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 86 / Monday, May 5, 2014 / Notices 25597 

preceding calendar year. Similarly, 

section 1128G(a)(2) of the Act requires 

applicable manufacturers and 

applicable GPOs to disclose any 

ownership or investment interests in 

such entities held by physicians or their 

immediate family members, as well as 

information on any payments or other 

transfers of value provided to such 

physician owners or investors. 

Applicable manufacturers must report 

the required payment and other transfer 

of value information annually to CMS in 

an electronic format. The statute also 

provides that applicable manufacturers 

and applicable GPOs must report 

annually to CMS the required 

information about physician ownership 

and investment interests, including 

information on any payments or other 

transfers of value provided to physician 

owners or investors, in an electronic 

format by the same date. Applicable 

manufacturers and applicable GPOs are 

subject to civil monetary penalties 

(CMPs) for failing to comply with the 

reporting requirements of the statute. 

We are required by statute to publish 

the reported data on a public Web site. 

The data must be downloadable, easily 

searchable, and aggregated. In addition, 

we must submit annual reports to the 

Congress and each state summarizing 

the data reported. Finally, section 

1128G of the Act generally preempts 

state laws that require disclosure of the 

same type of information by 

manufacturers. 

With this notice, we are announcing 

the addition of the dispute resolution 

and corrections process to this 

information collection request (ICR). 

The dispute resolution and corrections 

process was discussed in our initial 

submission to OMB. However, based on 

the detailed processes of review and 

corrections as well as the sensitivities 

around these processes, we felt it 

appropriate to solicit additional public 

feedback on how these interactions 

would occur. Therefore we are 

resubmitting a revised ICR for OMB 

review and approval. While we are 

submitting a revision of the entire ICR, 

we are specifically seeking comments 

on the dispute resolution and comment 

process. Form Number: CMS–10495 

(OCN: 0938–1237); Frequency: Once; 

Affected Public: Private sector— 

business or other for-profits; Number of 

Respondents: 227,157; Total Annual 

Responses: 457,454; Total Annual 

Hours: 3,099,297. (For policy questions 

regarding this collection contact Melissa 

Heesters at 410–786–0618.) 

Dated: April 30, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–10228 Filed 5–1–14; 11:15 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0435] 

Surveying, Leveling, or Alignment 

Laser Products; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Surveying, Leveling, or 

Alignment Laser Products.’’ This draft 

guidance, in question and answer 

format, is intended for manufacturers of 

laser products and outlines the FDA’s 

proposed approach regarding the 

applicability of FDA’s performance 

standard regulations to surveying, 

leveling, or alignment (SLA) laser 

products. SLA lasers are a subcategory 

of specific-purpose laser products that 

transmit laser radiation through open 

space for surveying, alignment, or 

leveling purposes. The draft guidance is 

not final nor is in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by August 4, 2014. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Surveying, 

Leveling, or Alignment Laser Products’’ 

to the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. Doyle, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4672, Silver Spring, 

MD 20993–0002, 301–796–5863. 

I. Background 

This draft guidance is intended to 

provide a brief summary of the FDA’s 

proposed approach on the applicability 

of performance standards for laser 

products to specific purpose SLA laser 

products. An SLA laser product is 

defined in 21 CFR 1040.10(b)(39) as ‘‘a 

laser product manufactured, designed, 

intended or promoted for one or more 

of the following uses: (i) Determining 

and delineating the form, extent, or 

position of a point, body, or area by 

taking angular measurement, (ii) 

positioning or adjusting parts in proper 

relation to one another, (iii) defining a 

plane, level, elevation, or straight line.’’ 

The topics that are addressed include 

the definition of an SLA laser product, 

examples of SLA laser products, design 

features of SLA laser products, the 

applicability of class limits to SLA laser 

products, and questions and answers 

relating to the application of FDA’s 

performance standard regulations to 

SLA laser products. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on surveying, leveling, or alignment 

laser products. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/


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