[Federal Register Volume 68, Number 167 (Thursday, August 28, 2003)]
[Notices]
[Pages 51788-51790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0364]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Annual Reports for New Drug Applications and 
Abbreviated New Drug Applications; 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availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--

[[Page 51789]]

Annual Reports for NDAs and ANDAs.'' This draft guidance is one in a 
series of guidance documents on providing regulatory submissions to FDA 
in electronic format. The draft guidance discusses issues related to 
the electronic submission of annual reports for approved new drug 
applications (NDAs) and abbreviated new drug applications (ANDAs) to 
FDA's Center for Drug Evaluation and Research (CDER). It is expected 
that the submission of these reports in electronic format will improve 
the agency's efficiency in processing, archiving, and reviewing the 
reports.

DATES: Submit written or electronic comments on the draft guidance by 
October 27, 2003. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management Branch 
(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electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5411, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Annual Reports for NDAs and ANDAs.'' The draft document provides 
guidance to industry regarding submission of annual reports in 
electronic format for approved NDAs and ANDAs. This draft guidance is 
consistent with the forthcoming guidance being developed on the 
submission of annual reports based on the Electronic Common Technical 
Document.
    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 providing 
annual reports for approved NDAs and ANDAs in electronic format. 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 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. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (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. 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 the following topics: (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 and other forms of 
information technology, when appropriate.
    Title: Draft Guidance for Industry on Providing Regulatory 
Submissions in Electronic Format--Annual Reports for NDAs and ANDAs.
    Description: FDA is issuing a draft guidance for industry on the 
electronic submission of annual reports for approved NDAs and ANDAs. 
The guidance is one in a series of guidance documents on providing 
regulatory submissions to FDA in electronic format. It is expected that 
the submission of these reports in electronic format will improve the 
agency's efficiency in processing, archiving, and reviewing the 
reports.
    Sections 314.70(d), 314.81(b)(2), and 314.98 of FDA regulations (21 
CFR 314.70(d), 314.81(b)(2), and 314.98) provide reporting requirements 
for submitting annual reports for approved NDAs and ANDAs. Section 
314.81(b)(2) and FDA Form 2252 (Transmittal of Periodic Reports for 
Drugs for Human Use) specify the information required in the submission 
of annual reports. The submission of annual reports under these 
regulations, including FDA Form 2252, is approved by OMB until March 
31, 2005, under OMB control number 0910-0001. The draft guidance states 
that this information, currently required to be submitted on paper, may 
be submitted in electronic format as described in the draft guidance.
    The draft guidance also requests information that is not 
specifically required in the regulations and is not approved by OMB 
under control number 0910-0001. Section 314.81(b)(2)(iv) requires that 
chemistry, manufacturing, and controls (CMC) changes be submitted in 
the annual report. To facilitate the review of this information, the 
draft guidance requests that applicants provide in electronic format a 
current list of approved CMC information to better document the changes 
occurring in applications. This information is currently requested in 
paper format in the guidance for industry entitled ``Format and Content 
for the CMC Section of an Annual Report'' (September, 1994) (see 
sections I and IV of part IV. Format and also attachment 1 of the 
guidance). The draft guidance requests that the list of approved CMC 
information include all information shown in attachment 1 of the 
September 1994 guidance, including: (1) The type and date of each 
change to each component; (2) the type of submission used to report the 
change (original, supplemental, or annual report); and (3) the date the 
change was reported and approved, if applicable.
    Description of Respondents: Applicants that are required to submit 
annual reports updating information in an approved NDA or ANDA.
    Burden Estimate: Table 1 of this document provides an estimate of 
the annual reporting burden for the

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submission of the current list of approved CMC information. Based on 
the number of annual reports received for approved NDAs and ANDAs in 
calendar year 2002, FDA estimates that approximately 2,589 annual 
reports will be submitted by approximately 295 applicants for approved 
NDAs, and approximately 4,991 annual reports will be submitted by 
approximately 240 applicants for approved ANDAs. FDA estimates that it 
will take an applicant approximately 1 hour to prepare and attach the 
list of approved CMC information as requested in the draft guidance.
    FDA invites comments on this analysis of information collection 
burdens.

                                   Table 1.--Estimated Annual Reporting Burden
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                                 Annual of Responses
            No. of Respondents     per Respondent       Total Responses   Hours per Response      Total Hours
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NDAs              295                    9                2,589                   1               2,589
ANDAs             240                   21                4,991                   1               4,991
Total       ..................  ....................  ..................  ..................      7,580
 Hours
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    To ensure that comments on the information collection are received, 
OMB recommends that written comments be electronically mailed to 
[email protected] or faxed to the Office of Information and 
Regulatory Affairs, OMB, Attn: Desk Officer for FDA, FAX: 202-395-6974.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21985 Filed 8-27-03; 8:45 am]
BILLING CODE 4160-01-S