[Federal Register: June 1, 2009 (Volume 74, Number 103)]
[Notices]
[Page 26248-26249]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn09-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0464] (formerly Docket No. 2005N-0403)
Guidance for Industry on Providing Regulatory Submissions in
Electronic Format--Drug Establishment Registration and Drug Listing;
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 guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' This guidance document is designed to assist industry
(e.g., manufacturers, repackers, and relabelers) with the electronic
submission of drug establishment registration and drug listing
information. Specifically, the document provides guidance to industry
on the types of information to include for purposes of drug
establishment registration and drug listing and on how to prepare and
submit the information in an electronic format that FDA can process,
review, and archive.
DATES: Submit written or electronic comments on agency guidances at
any time. As of June 1, 2009, FDA will only accept electronic
submissions of drug establishment registration and drug
[[Page 26249]]
listing information, unless a waiver is granted.
ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Critical Path Programs (HF-18), Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your requests. The guidance may also be
obtained by mail by calling the Office of Critical Path Programs at
301-827-1512. Submit written comments on the 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.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lonnie Smith, Office of Critical Path
Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-0011.
SUPPLEMENTARY INFORMATION:
I. Background
Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360) and section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262) and 21 CFR part 207.
Fundamental to FDA's mission to protect the public health is the
collection of this information, which is used for important activities
such as postmarket surveillance for serious adverse drug reactions,
inspection of drug manufacturing and processing facilities, and
monitoring of drug products imported into the United States.
Comprehensive, accurate, and up-to-date information is critical to
conducting these activities with efficiency and effectiveness.
Changes in the act, resulting from the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85), require that drug
establishment registration and drug listing information be submitted
electronically, unless a waiver is granted. Before FDAAA was enacted,
section 510(p) of the act expressly provided that drug establishment
registration information must be submitted electronically, based on a
finding that electronic receipt was feasible, and section 510(j) of the
act stipulated that drug listing information must be submitted in the
form and manner prescribed by FDA. Section 224 of FDAAA, which amends
section 510(p) of the act, now expressly requires drug listing to be
submitted by electronic means in addition to requiring electronic drug
establishment registration.
Drug establishment registration and drug listing information have,
until now, been submitted using a paper-based format, i.e., Form FDA
2656 (Registration of Drug Establishment/Labeler Code Assignment), Form
FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors). Moving from a
paper-based format to an electronic system will improve the timeliness
and accuracy of the submissions.
This guidance is designed to assist manufacturers, repackers, and
relabelers with electronic submissions of drug establishment
registrations and drug listing information. The guidance and
accompanying technical documents explain (among other things):
The statutory requirement to submit electronically drug
establishment registration and drug listing information;
How to create a Structured Product Labeling (SPL) file for
submitting drug establishment registration and drug listing information
to FDA through the Electronic Submissions Gateway (ESG) using defined
code sets and codes, i.e., a language recognized by the computer
system; and
That FDA intends to no longer accept drug establishment
registration and drug listing information in paper format, unless a
waiver is granted.
FDA encourages manufacturers, repackers, and relabelers to establish a
gateway account as soon as possible so that they will be prepared to
electronically submit drug establishment registration and drug listing
information by June 1, 2009.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on providing regulatory submissions in
electronic format for drug establishment registration and drug listing
information. 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 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.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection(s) of information in this guidance was approved under OMB
control number 0910-0045.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, http://www.fda.gov/cvm/guidance/guidance.html, and
http://www.regulations.gov.
Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12743 Filed 5-28-09; 4:15 pm]
BILLING CODE 4160-01-S