[Federal Register Volume 65, Number 48 (Friday, March 10, 2000)]
[Notices]
[Pages 13010-13012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5866]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0892]


Draft Guidance for Industry on the Content and Format of New Drug 
Applications and Abbreviated New Drug Applications for Certain Positron 
Emission Tomography Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``PET Drug 
Applications --Content and Format for NDA's and ANDA's.'' The draft 
guidance is intended to assist manufacturers of certain positron 
emission tomography (PET) drugs in submitting new drug applications 
(NDA's) or abbreviated new drug applications (ANDA's) in accordance 
with a notice entitled ``Positron Emission Tomography Drug Products; 
Safety and Effectiveness of Certain PET Drugs for Specific 
Indications'' published elsewhere in this issue of the Federal 
Register.

DATES: Submit written comments on the draft guidance and the collection 
of information provisions by June 8, 2000. General comments on agency 
guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http:/www.fda.gov/cder/guidance/index.htm and at http:/
www.fda.gov/cder/regulatory/pet. Submit written requests for single 
copies of the draft guidance to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed 
adhesive label to assist the office in processing your requests. Submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document.

[[Page 13011]]


FOR FURTHER INFORMATION CONTACT: Robert K. Leedham, Jr., Center for 
Drug Evaluation and Research (HFD-160), 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-7510.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``PET Drug Applications--Content 
and Format for NDA's and ANDA's.'' The draft guidance is intended to 
assist the manufacturers of certain PET drugs--fludeoxyglucose (FDG) F 
18 injection, ammonia N 13 injection, and sodium fluoride F 18 
injection--in submitting NDA's and ANDA's in accordance with a notice 
entitled ``Positron Emission Tomography Drug Products; Safety and 
Effectiveness of Certain PET Drugs for Specific Indications'' published 
elsewhere in this issue of the Federal Register. The notice invites the 
manufacturers of these PET drugs to submit NDA's of the type described 
in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 355(b)(2)) or ANDA's under section 505(j) of the act. 
The draft guidance states when submission of a 505(b)(2) application or 
ANDA is appropriate, and it describes the information that 
manufacturers of these PET drugs should include in each type of 
application.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on the submission of 
505(b)(2) applications and ANDA's in accordance with a notice published 
elsewhere in this issue of the Federal Register. 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, regulations, or 
both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one 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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
The Paperwork Reduction Act of 1995
    Under the Paperwork Reduction Act of 1995 (the 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. ``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 provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comment on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Title: Draft Guidance for Industry: PET Drug Applications--Content 
and Format for NDA's and ANDA's.
    Description: The draft guidance is intended to assist manufacturers 
of certain PET drugs in submitting NDA's or ANDA's in accordance with 
the notice entitled ``Positron Emission Tomography Drug Products; 
Safety and Effectiveness of Certain PET Drugs for Specific 
Indications.''
    Description of Respondents: Manufacturers submitting NDA's or 
ANDA's for certain PET drugs.
    Burden Estimate: The draft guidance is intended to assist 
manufacturers in preparing NDA's or ANDA's for FDG F 18 injection, 
ammonia N 13 injection, and sodium fluoride F 18 injection submitted in 
accordance with a notice entitled ``Positron Emission Tomography Drug 
Products; Safety and Effectiveness of Certain PET Drugs for Specific 
Indications'' published elsewhere in this issue of the Federal 
Register. Most of the collection of information resulting from this 
draft guidance is contained in current regulations for submitting NDA's 
and ANDA's to FDA under part 314 (21 CFR part 314), and has already 
been reviewed and approved by OMB as follows: (1) Information 
collection required under part 314 is approved by OMB until November 
30, 2001, under OMB control number 0910-0001; (2) information 
collection required on Form FDA-356h (Application to Market a New Drug, 
Biologic, or Antibiotic Drug for Human Use) is approved by OMB until 
April 30, 2000, under OMB control number 0910-0338; and (3) information 
collection required on Form FDA-3397 (User Fee Cover Sheet) is approved 
by OMB until April 30, 2001, under OMB control number 0910-0297.
    There are three types of submissions requested under the draft 
guidance that are not specifically required under part 314 or Form FDA-
356h or Form FDA-3397 and, therefore, need to be approved by OMB under 
the PRA:
    1. Cover letter--Manufacturers should include with each NDA or ANDA 
a signed and dated cover letter with a clear, brief introductory 
statement. The draft guidance specifies the information that should be 
contained in the cover letter: (1) Purpose of the application; (2) type 
of submission; (3) name, title, signature, and address of the 
applicant; (4) established name and proprietary name for the proposed 
drug product; and (5) number of volumes submitted.
    2. Letter of authorization--Manufacturers using an agent or 
consultant to act on their behalf should include with each NDA or ANDA 
a letter of authorization, signed and attached to the cover letter, 
that identifies the authorized agent or consultant.
    3. Sample statement--Manufacturers should include a sample 
statement when responding to an FDA request for a representative sample 
of the drug product proposed for marketing, the drug substance or 
components used in the manufacture of the drug product, or the 
reference standards. The draft guidance provides an example of a sample 
statement notifying FDA that the applicant is supplying a 
representative sample of the drug product, the drug substance or 
components, or the reference standards.
    Based on FDA's experience with reviewing NDA's and ANDA's and on 
its knowledge of the PET drug manufacturing community, FDA has 
estimated, in table 1 of this document: (1) The number of respondents 
expected to submit cover letters, letters of authorization, and sample 
statements with their NDA's or ANDA's as set forth in the draft 
guidance; (2) the number of cover letters, letters of authorization, 
and sample statements that respondents will submit with their NDA's or 
ANDA's as set forth in the draft guidance; and (3)

[[Page 13012]]

the amount of time it will take respondents to submit cover letters, 
letters of authorization, and sample statements with their NDA's or 
ANDA's as set forth in the draft guidance.

                                   Table1.--Estimated Annual Reporting Burden1
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                                                     Number of
        NDA's and ANDA's              No. of       Responses per   Total Annual      Hours per      Total Hours
                                    Respondents     Respondent       Responses       Response
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Cover letters                          50               1              50             1/2              25
Letters of authorization               20               1              20             1/2              10
Sample statements                       1               1               1             1/2                .5
Total                                                                                                  35.5
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 6, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5866 Filed 3-7-00; 11:42 am]
BILLING CODE 4160-01-F