Daily Rules, Proposed Rules, and Notices of the Federal Government
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On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to FDA's generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring owners of facilities producing generic drug products and active pharmaceutical ingredients (API) and certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually.
Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Once the self-identification process has been completed, FDA will determine the fees and publish the amounts in the
This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how FDA will implement the self-identification requirement contained in GDUFA. As required by GDUFA, in the coming weeks FDA will issue a self-identification requirement notice in the
To facilitate the implementation of the self-identification requirement in GDUFA, FDA is establishing a new system for the electronic self-identification of generic industry facilities, sites, and organizations. Entities that are required to register and list under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, and those entities required to self-identify under GDUFA, will submit information separately to the respective systems. Each system will populate its own database to meet unique requirements and deadlines. The new GDUFA system will use the same platform and technical standards already familiar to manufacturers required to register and list.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on self-identification of generic drug facilities, sites, and organizations. 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.
Interested persons may submit to the Division of Dockets Management (see
Under the Paperwork Reduction Act of 1995 (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 that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 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
With respect to the collection of information associated with this draft guidance, FDA invites comments on the following topics: (1) Whether the proposed information collected is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimated burden of the proposed information collected, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of information collected on the
Under GDUFA, and as described in the draft guidance, electronic self-identification will be required by all facilities, sites, and organizations involved in the development and manufacturing of generic drugs identified or intended to be identified in an approved or pending FDA generic drug submission. The electronic self-identification requirement applies equally to all domestic and foreign facilities and is independent of the obligation to pay user fees.
Generic drug facilities, sites, and organizations required under GDUFA to self-identify include:
1. Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
2. Sites and organizations that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
3. Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
5. Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).
All of the facilities, sites, and organizations listed above are currently required to register and list except for #4.
FDA is establishing a new system for self-identification of generic industry facilities, sites, and organizations. Entities that are required to register and list, and those that are required to self-identify, will submit information to both systems separately. Each system will populate its own database to meet unique requirements and deadlines. Although separate, both systems are built on a common process already familiar to manufacturers required to register and list. This will minimize the cost and effort associated with compliance.
FDA will use the same electronic exchange standards and formats for self-identification that are used in the Drug Registration and Listing System (eDRLS) including XML file formats, which conform to message standards for Structured Product Labeling (SPL). Facilities, sites, and organizations will be able to generate electronic SPL files in the free eSubmitter tool available on FDA's Web site, or other commercially available tools, and submit the files through FDA's Electronic Submissions Gateway. Facilities, sites, and organizations will be required to provide Data Universal Numbering System (D-U-N-S) numbers and Facility Establishment Identifiers (FEI) to enable quick and accurate identification of registrants as well as facilities, sites, and organizations. They will also be required to submit information about the registrant, facility, and SPL file. Requested information will include:
FDA estimates that approximately 2,650 facilities, sites, and organizations (“number of respondents” in Table 1) will submit the self-identification information set forth above and described in the draft guidance, resulting in approximately 3,000 annual submissions (“total annual responses” in Table 1). Although there will be one self-identification submission annually by each facility, site, and organization, we rounded the estimate upwards to approximately 3,000 to account for any revisions to the submissions, if needed. These estimates are based on FDA's database of manufacturers in eDRLS and are consistent with conversations between the Agency and representatives of regulated industry during the generic drug user fee negotiations. We also estimate that preparing and submitting this information will take approximately 2.5 hours for each facility (“hours per response” in Table 1). We base this estimate on the hour burden estimate for submitting drug registration information electronically under eDRLS, as approved by OMB under control number 0910-0045. Most facilities, sites, and organizations are familiar with the eDRLS process and already have the self-identification information available. Entities that are required to register would submit this information separately to the eDRLS system, as approved by OMB under control number 0910-0045.
FDA estimates the burden of this collection of information as follows:
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