Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices 19269 

by the Secretary, HHS, advising the 

Secretary on whether there is a class of 

employees at any Department of Energy 

facility who were exposed to radiation 

but for whom it is not feasible to 

estimate their radiation dose, and on 

whether there is a reasonable likelihood 

that such radiation doses may have 

endangered the health of members of 

this class. The Subcommittee on 

Procedures Review was established to 

aid the ABRWH in carrying out its duty 

to advise the Secretary, HHS, on dose 

reconstructions. The Subcommittee on 

Procedures Review is responsible for 

overseeing, tracking, and participating 

in the reviews of all procedures used in 

the dose reconstruction process by the 

NIOSH Division of Compensation 

Analysis and Support (DCAS) and its 

dose reconstruction contractor. 

Matters To Be Discussed: The agenda 

for the Subcommittee meeting includes 

discussion of the following ORAU and 

DCAS procedures: OTIB–0055 

(‘‘Conversion from NCRP Report 38 

Neutron Quality Factors to ICRP Pub. 

60’’), Program Evaluation Report (PER)- 

0005 (‘‘Misinterpreted Application of 

the External Dose Factor {Hanford}’’), 

PER 014 (‘‘Construction Trades 

Workers’’), PER 017 (‘‘Evaluation of 

Incomplete Internal Dose Records from 

Idaho, Argonne-East and Argonne-West 

National Laboratories’’), PER 020 

(‘‘Blockson Technical Basis 

Document’’), PER 029 (‘‘Hanford TBD 

Revision’’), PER 031 (‘‘Y–12 TBD 

Revisions’’), PER 037 (‘‘Ames TBD 

Revision’’), PER 038 (‘‘Hooker 

Electrochemical TBD Revision’’), 

ORAUT–PROC–0044 (‘‘Special 

Exposure Cohort’’); DCAS Report 0053 

(‘‘Stratified Co-Worker Sets’’); and a 

continuation of the comment-resolution 

process for other dose reconstruction 

procedures under review by the 

Subcommittee. 

The agenda is subject to change as 

priorities dictate. 

In the event an individual wishes to 

provide comments, written comments 

may be submitted. Any written 

comments received will be provided at 

the meeting and should be submitted to 

the contact person below in advance of 

the meeting. 

Contact Person for More Information: 

Theodore Katz, Designated Federal 

Official, NIOSH, CDC, 1600 Clifton 

Road, Mailstop E–20, Atlanta Georgia 

30333, Telephone (513) 533–6800, Toll 

Free 1 (800) CDC–INFO, email 

dcas@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. 2013–07367 Filed 3–28–13; 8:45 am] 

BILLING CODE 4163–18–P 

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 

Notice of Cancellation: This 

document corrects a notice that was 

published in the Federal Register on 

March 21, 2013 (78 FR 06434), 

announcing a teleconference that would 

include the initial review, discussion, 

and evaluation of applications received 

in response to ‘‘Indoor Environment of 

Low-Income Renovated Multifamily 

Housing in the Western Region of the 

United States (U01), Funding 

Opportunity Announcement EH–13– 

001.’’ This meeting is canceled. 

Notice will be provided if the meeting 

is rescheduled in accordance with 

section 10(a)(2) of the Federal Advisory 

Committee Act (Pub.L. 92–463). 

Contact Person for More Information: 

J. Felix Rogers, Ph.D., M.P.H., Scientific 

Review Officer, National Center for 

Injury Prevention and Control, CDC, 

4770 Buford Highway, NE., Mailstop 

F63, Atlanta, Georgia 30341, Telephone: 

(770) 488–4334. 

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. 2013–07366 Filed 3–28–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1457–NC] 

Medicare and Medicaid Programs; 

Announcement of Application From a 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made in accordance with section 

1138(a)(2) of the Social Security Act (the 

Act). This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

May 28, 2013. 

ADDRESSES: In commenting, refer to file 

code CMS–1457–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1457–NC, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1457–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments to a regulations 

staff member ONLY to the following 

addresses: 

mstockstill on DSK4VPTVN1PROD with NOTICES

19270 Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the Hubert 

H. Humphrey Building is not readily 

available to persons without Federal 

government identification, commenters are 

encouraged to leave their comments in the 

CMS drop slots located in the main lobby of 

the building. A stamp-in clock is available for 

persons wishing to retain a proof of filing by 

stamping in and retaining an extra copy of 

the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Taft, (410) 786–4561. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

the Public Health Service Act (42 U.S.C. 

273(b)(1)) and our regulations at 42 CFR 

486.306. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and 

Medicaid are required to work with that 

OPO in providing organs for transplant, 

pursuant to section 1138(a)(1)(C) of the 

Social Security Act (the Act) and our 

regulations at 42 CFR 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement only with its 

designated OPO to identify potential 

donors. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2)(A) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to submit 

comments during the 60-day comment 

period beginning on the publication 

date in the Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by 42 CFR 486.308(e), 

the following hospital has requested a 

waiver to enter into an agreement with 

a designated OPO other than the OPO 

designated for the service area in which 

the hospital is located: 

Southern Ocean Medical Center in 

Manahawkin, New Jersey, is requesting 

a waiver to work with: New Jersey 

Sharing Network, 691 Central Avenue, 

New Providence, NJ 07974. 

The Hospital’s Designated OPO is: 

Gift of Life Donor Program, 401 N 3rd 

Street, Philadelphia, PA 19123. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C.35). 

V. Response to Comments 

We will consider all comments we 

receive by the date and time specified 

in the DATES section of this preamble, 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Notices 19271 

and, when we proceed with a 

subsequent document, we will respond 

to the comments in the preamble to that 

document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: March 25, 2013 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–07343 Filed 3–28–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369; (Formerly 

Docket No. 2007D–0168)] 

Draft Guidance for Industry on 

Bioequivalence Recommendations for 

Metronidazole Vaginal Gel; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Metronidazole 

Vaginal Gel.’’ The guidance provides 

specific recommendations on the design 

of bioequivalence (BE) studies to 

support abbreviated new drug 

applications (ANDAs) for metronidazole 

vaginal gel. 

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 comments 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 May 28, 2013. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

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. Send 

one self-addressed adhesive label to 

assist that office in 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: Kris 

Andre, Center for Drug Evaluation and 

Research (HFD–600), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9326. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311; FDA–2007–D–0433), 

FDA announced the availability of a 

guidance for industry entitled 

‘‘Bioequivalence Recommendations for 

Specific Products,’’ which explained the 

process that would be used to make 

product-specific bioequivalence (BE) 

recommendations available to the 

public on FDA’s Web site at http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. As described in that 

guidance, FDA adopted this process as 

a means to develop and disseminate 

product-specific BE recommendations 

and provide a meaningful opportunity 

for the public to consider and comment 

on those recommendations. This notice 

announces the availability of draft BE 

recommendations for metronidazole 

vaginal gel. 

New drug application 020208 for 

MetroGel-Vaginal (metronidazole) 

vaginal gel, 0.75%, was initially 

approved by FDA in August 1992. On 

October 31, 2006, FDA approved ANDA 

077264 for a generic version of 

MetroGel-Vaginal 0.75% 

(metronidazole). FDA is now issuing a 

draft guidance for industry on BE 

recommendations for generic 

metronidazole vaginal gel (Draft 

Metronidazole Vaginal Gel BE 

Recommendations). 

In March 2006, Foley & Lardner LLP 

(the petitioner) submitted a citizen 

petition requesting that FDA require 

that any ANDA referencing Metro-Gel 

Vaginal meet certain conditions, 

including conditions related to 

demonstrating BE (Docket No. FDA– 

2006–P–0080). FDA is reviewing the 

issues raised in the petition. FDA will 

consider any comments on the Draft 

Metronidazole Vaginal Gel BE 

Recommendations in responding to the 

citizen petition. 

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 the design of BE studies to support 

ANDAs for metronidazole vaginal gel. 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 statutes 

and regulations. 

II. Comments 

Interested persons may submit either 

written comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments to http:// 

www.regulations.gov. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: March 25, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–07296 Filed 3–28–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

[Docket Number OIG–1302–N] 

Special Fraud Alert: Physician-Owned 

Entities 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Notice. 

SUMMARY: This Special Fraud Alert 

addresses physician-owned entities that 

derive revenue from selling, or 

arranging for the sale of, implantable 

medical devices ordered by their 

physician-owners for use in procedures 

the physician-owners perform on their 

own patients at hospitals or ambulatory 

surgical centers (ASCs). 

DATES: These regulations are effective 

on March 29, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Patrice S. Drew, Department of Health 

and Human Services, Office of Inspector 

General, Congressional and Regulatory 

Affairs, at (202) 619–1368. 

mstockstill on DSK4VPTVN1PROD with NOTICES