[Federal Register: August 28, 2003 (Volume 68, Number 167)]
[Notices]
[Page 51788-51790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au03-56]
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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Draft Guidance for Industry on Providing Regulatory Submissions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availability of a draft guidance for industry entitled ``Providing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 This draft guidance is one in a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 The draft guidance discusses issues related to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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management Branch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electronic access to the draft guidance document.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:
levinr@cder.fda.gov.
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FDA is announcing the availability of a draft guidance for industry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
[[Page 51790]]
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
fyokata@omb.eop.gov 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