Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Notices 55145 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Dated: September 9, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–18655 Filed 9–19–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 1998D–0266] 

Draft Guidance on Current Good 

Manufacturing Practice for Positron 

Emission Tomography Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘PET Drug Products—Current Good 

Manufacturing Practice (CGMP).’’

Elsewhere in this issue of the Federal 

Register, we are issuing proposed 

regulations on CGMPs for positron 

emission tomography (PET) drug 

products. We are making the draft 

guidance available so that producers of 

PET drugs can better understand FDA’s 

thinking on CGMP compliance if the 

proposed regulations become final after 

notice-and-comment rulemaking. 

DATES: Submit written or electronic 

comments on the draft guidance by 

December 19, 2005. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance. 

FOR FURTHER INFORMATION CONTACT: 

Brenda Uratani, Center for Drug 

Evaluation and Research (HFD–320), 

Food and Drug Administration, 11919 

Rockville Pike, Rockville, MD 20852, 

301–827–8941. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On November 21, 1997, the President 

signed the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act) (Public Law 

105–115) into law. Section 121(c)(1)(A) 

of the Modernization Act directs us to 

establish appropriate approval 

procedures and CGMP requirements for 

PET drugs. Section 121(c)(1)(B) states 

that, in adopting such requirements, we 

must take due account of any relevant 

differences between not-for-profit 

institutions that compound PET drugs 

for their patients and commercial 

manufacturers of the drugs. Section 

121(c)(1)(B) also directs us to consult 

with patient advocacy groups, 

professional associations, 

manufacturers, and physicians and 

scientists who make or use PET drugs as 

we develop PET drug CGMP 

requirements and approval procedures. 

We presented our initial tentative 

approach to PET drug CGMP 

requirements and responded to 

numerous questions and comments 

about that approach at a public meeting 

on February 19, 1999. In the Federal 

Register of September 22, 1999 (64 FR 

51274), FDA published preliminary 

draft regulations on CGMP for PET drug 

products. FDA received comments on 

the preliminary draft regulations at 

another public meeting on the same 

subject on September 28, 1999. FDA 

made changes in the working draft in 

response to the public comments. In the 

Federal Register of April 1, 2002 (67 FR 

15344), FDA published a preliminary 

draft proposed rule, in conjunction with 

the first draft guidance (67 FR 15404, 

April 1, 2002). FDA received written 

and oral comments on the preliminary 

draft proposed rule and the first draft 

guidance at a public meeting on May 21, 

2002, and written comments after the 

May 2002 meeting, FDA has taken all 

comments into consideration in revising 

the preliminary draft proposed rule and 

the draft guidance. The draft guidance 

provides more details for discussion 

purposes on acceptable approaches to 

complying with the proposed 

regulations should they be published in 

final form. 

Elsewhere in this issue of the Federal 

Register, we are publishing a proposed 

rule on CGMP for PET drug products. 

We are making this draft guidance 

available so that PET drug producers 

can better understand FDA’s thinking 

on compliance with the proposed CGMP 

regulations if they become final after 

notice-and-comment rulemaking. We 

invite comments on whether the draft 

guidance would be a useful 

accompaniment to the proposed rule. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

paper copies of mailed comments are to 

be submitted, except that individuals 

may submit one paper copy. Comments 

are to be identified with the docket 

number found in brackets in the 

heading of this document. The draft 

guidance and received comments are 

available for public examination in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm, http://www.fda.gov/ohrms/ 

dockets/default.htm, or http:// 

www.fda.gov/cder/fdama under 

‘‘Section 121—PET (Positron Emission 

Tomography).’’

Dated: September 1, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18509 Filed 9–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

National Indian Health Board 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice to supplement the singlesource cooperative agreement with the 

National Indian Health Board. 

SUMMARY: The Indian Health Service 

(IHS) announces a supplement to the 

single-source cooperative agreement 

award to the National Indian Health 

Board (NIHB) for costs in providing 

advice and technical assistance to the 

IHS on behalf of federally recognized 

Tribes in the area of health care policy 

analysis and program development. The