[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Pages 26248-26249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12743]


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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