Federal Register Notice Announcing FDA Draft Guidance on PET Drug Applications for NDA's and ANDA's

June 30, 2003

Federal Register Notice Announcing FDA Draft Guidance on PET Drug Applications for NDA's and ANDA's

[Federal Register: March 10, 2000 (Volume 65, Number 48)]

[Notices]

Page 13010-13012

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr10mr00-72]

-----------------------------------------------------------------------

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Draft Guidance for Industry on the Content and Format of New DrugApplications and Abbreviated New Drug Applications for Certain Positronmission Tomography Drug Products;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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing theavailability of a draft guidance for industry entitled ``PET DrugApplications --Content and Format for NDA's and ANDA's.'' The draftguidance is intended to assist manufacturers of certain positronemission tomography (PET) drugs in submitting new drug applications(NDA's) or abbreviated new drug applications (ANDA's) in accordancewith a notice entitled ``Positron Emission Tomography Drug Products;Safety and Effectiveness of Certain PET Drugs for SpecificIndications'' published elsewhere in this issue of the FederalRegister.

DATES: Submit written comments on the draft guidance and the collectionof information provisions by June 8, 2000.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

ADDRESSES: Copies of this draft guidance for industry are available onthe Internet at http:/www.fda.gov/cder/guidance/index.htm and at http:/www.fda.gov/cder/regulatory/pet. Submit written requests for singlecopies of the draft guidance to the Drug Information Branch (HFD-210),Center for Drug Evaluation and Research, Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857.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

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

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of adraft guidance for industry entitled ``PET Drug Applications--Contentand Format for NDA's and ANDA's.'' The draft guidance is intended toassist the manufacturers of certain PET drugs--fludeoxyglucose (FDG) F18 injection, ammonia N 13 injection, and sodium fluoride F 18injection--in submitting NDA's and ANDA's in accordance with a noticeentitled ``Positron Emission Tomography Drug Products; Safety andEffectiveness of Certain PET Drugs for Specific Indications'' publishedelsewhere in this issue of the Federal Register. The notice invites themanufacturers of these PET drugs to submit NDA's of the type describedin section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (theact) (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 orANDA is appropriate, and it describes the information thatmanufacturers of these PET drugs should include in each type ofapplication.

This Level 1 draft guidance is being issued consistent with FDA'sgood guidance practices (62 FR 8961, February 27, 1997). The draftguidance represents the agency's current thinking on the submission of505(b)(2) applications and ANDA's in accordance with a notice publishedelsewhere in this issue of the Federal Register. It does not create orconfer any rights for or on any person and does not operate to bind FDAor the public. An alternative approach may be used if such approachsatisfies the requirements of the applicable statutes, regulations, orboth.

Interested persons may submit to the Dockets Management Branch(address above) written comments on the draft guidance. Two copies ofany comments are to be submitted, except that individuals may submitone copy. Comments are to be identified with the docket number found inbrackets in the heading of this document. The draft guidance andreceived comments are available for public examination in the DocketsManagement 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 ofManagement and Budget (OMB) for each collection of information theyconduct or sponsor. ``Collection of information'' is defined in 44U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests orrequirements that members of the public submit reports, keep records,or provide information to a third party. Section 3506(c)(2)(A) of thePRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a60-day notice in the Federal Register concerning each proposedcollection of information before submitting the collection to OMB forapproval. To comply with this requirement, FDA is publishing notice ofthe proposed collection of information set forth in this document.

With respect to the following collection of information, FDAinvites comment on: (1) Whether the proposed collection of informationis necessary for the proper performance of FDA's functions, includingwhether the information will have practical utility; (2) the accuracyof FDA's estimate of the burden of the proposed collection ofinformation, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection on respondents, including through the use of automatedcollection techniques, when appropriate, and other forms of informationtechnology.

Title: Draft Guidance for Industry: PET Drug Applications--Contentand Format for NDA's and ANDA's.

Description: The draft guidance is intended to assist manufacturersof certain PET drugs in submitting NDA's or ANDA's in accordance withthe notice entitled ``Positron Emission Tomography Drug Products;Safety and Effectiveness of Certain PET Drugs for SpecificIndications.''

Description of Respondents: Manufacturers submitting NDA's orANDA's for certain PET drugs.Burden Estimate: The draft guidance is intended to assistmanufacturers in preparing NDA's or ANDA's for FDG F 18 injection,ammonia N 13 injection, and sodium fluoride F 18 injection submitted inaccordance with a notice entitled ``Positron Emission Tomography DrugProducts; Safety and Effectiveness of Certain PET Drugs for SpecificIndications'' published elsewhere in this issue of the FederalRegister. Most of the collection of information resulting from thisdraft guidance is contained in current regulations for submitting NDA'sand ANDA's to FDA under part 314 (21 CFR part 314), and has alreadybeen reviewed and approved by OMB as follows: (1) Informationcollection required under part 314 is approved by OMB until November30, 2001, under OMB control number 0910-0001; (2) informationcollection required on Form FDA-356h (Application to Market a New Drug,Biologic, or Antibiotic Drug for Human Use) is approved by OMB untilApril 30, 2000, under OMB control number 0910-0338; and (3) informationcollection required on Form FDA-3397 (User Fee Cover Sheet) is approvedby OMB until April 30, 2001, under OMB control number 0910-0297.There are three types of submissions requested under the draftguidance that are not specifically required under part 314 or Form FDA-356h or Form FDA-3397 and, therefore, need to be approved by OMB underthe PRA:

1. Cover letter--Manufacturers should include with each NDA or ANDAa signed and dated cover letter with a clear, brief introductorystatement. The draft guidance specifies the information that should becontained in the cover letter: (1) Purpose of the application; (2) typeof submission; (3) name, title, signature, and address of theapplicant; (4) established name and proprietary name for the proposeddrug product; and (5) number of volumes submitted.

2. Letter of authorization--Manufacturers using an agent orconsultant to act on their behalf should include with each NDA or ANDAa letter of authorization, signed and attached to the cover letter,that identifies the authorized agent or consultant.

3. Sample statement--Manufacturers should include a samplestatement when responding to an FDA request for a representative sampleof the drug product proposed for marketing, the drug substance orcomponents used in the manufacture of the drug product, or thereference standards. The draft guidance provides an example of a samplestatement notifying FDA that the applicant is supplying arepresentative sample of the drug product, the drug substance orcomponents, or the reference standards.Based on FDA's experience with reviewing NDA's and ANDA's and onits knowledge of the PET drug manufacturing community, FDA hasestimated, in table 1 of this document: (1) The number of respondentsexpected to submit cover letters, letters of authorization, and samplestatements with their NDA's or ANDA's as set forth in the draftguidance; (2) the number of cover letters, letters of authorization,and sample statements that respondents will submit with their NDA's orANDA's as set forth in the draft guidance; and (3)the amount of time it will take respondents to submit cover letters,letters of authorization, and sample statements with their NDA's orANDA's as set forth in the draft guidance.

Table1.--Estimated Annual Reporting Burden<SUP>1</SUP>

----------------------------------------------------------------------------------------------------------------

Number ofNDA's and ANDA's No. of Responses per Total Annual Hours per Total HoursRespondents Respondent Responses Response

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

\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]