Source: https://www.federalregister.gov/documents/2009/07/28/E9-17963/applications-for-food-and-drug-administration-approval-to-market-a-new-drug-postmarketing-reports
Timestamp: 2016-10-01 05:07:57
Document Index: 303074076

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:: Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
A Rule by the Food and Drug Administration on 07/28/2009
37163-37168
https://www.federalregister.gov/d/E9-17963
In the Federal Register of September 29, 2008 (73 FR 56487), FDA published a direct final rule to amend § 314.3 (21 CFR 314.3) to add a definition of “authorized generic drug” and § 314.81 (21 CFR 314.81) to require that an NDA holder specifically report that it has marketed an authorized generic drug during the applicable time period. We explained that we issued this rule as a direct final rule because we believed it was noncontroversial and that there was little likelihood of receiving significant Start Printed Page 37164adverse comments. We concurrently published in the Federal Register of September 29, 2008 (73 FR 56529) a companion proposed rule, identical in substance to the direct final rule, that provided a procedural framework from which to proceed with standard notice-and-comment rulemaking in the event we were required to withdraw the direct final rule because of significant adverse comments. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. Any comments received under the companion proposed rule were treated as comments regarding the direct final rule and vice versa. A full description of FDA's policy on direct final rule procedures may be found in a guidance document published in the Federal Register of November 21, 1997 (62 FR 62466).
Publish on its Internet site a complete list of all authorized generic drugs included in an annual report submitted to the agency after January 1, 1999, consisting of the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market; Update the list quarterly; and
For purposes of publishing the list, section 505(t)(3) of the act defines the term “authorized generic drug” as a “listed drug (as that term is used in [section 505(j) of the act]) that has been approved under [section 505(c) of the act] and is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.” On June 27, 2008, based on information available to FDA at that time, the agency initially published the list of authorized generic drugs on FDA's Web site at http://www.fda.gov/​cder/​ogd/​AG_​Listing.htm.
After considering the comments, we have concluded that it is appropriate to make a revision to the proposed rule to permit e-mail submission of the required information in addition to regular mail, including courier delivery. The final rule revises proposed § 314.81(b)(2)(ii)(b) to allow NDA holders to send the required information to the Authorized Generics electronic mailbox at AuthorizedGenerics@fda.hhs.gov with “Authorized Generic Submission” indicated in the subject line.
Finally, on our own initiative, we have also revised § 314.81(b)(2)(ii)(b) to provide a new mailing address (street address) for submissions made by regular mail.
We are amending our regulations in § 314.3 (21 CFR 314.3) to add a definition for the term “authorized generic drug.” The definition provides that an authorized generic drug is a listed drug (as defined in § 314.3 (21 CFR 314.3)) that has been approved under section 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.
We are also amending our regulations in § 314.81 (21 CFR 314.81) to require that an NDA holder specifically report that it has marketed an authorized generic drug during the applicable time period. Section 314.81(b)(2) requires that an NDA holder submit an annual report within 60 days of the anniversary date of approval of an NDA for every NDA it holds. We are amending § 314.81 by redesignating paragraph (b)(2)(ii) regarding distribution data as paragraph (b)(2)(ii)(a), and adding a new paragraph (b)(2)(ii)(b) regarding marketing of authorized generic drugs. Under this new paragraph, if an authorized generic drug was marketed under an NDA, or Start Printed Page 37165ceased to be marketed, during the reporting year, the annual report must list the date the authorized generic drug entered the market, or the date the authorized generic drug ceased being distributed, and the corresponding trade or brand name. Each dosage form and/or strength is a different authorized generic drug and should be listed separately. The first annual report submitted after implementation of this regulation must include the required marketing information for any authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999.
(Response) FDA appreciates the supportive comments. Regarding the submission of additional information suggested by the commenter, note that this final rule requires, as we proposed, that annual reports list the date each authorized generic drug entered the market, the date each authorized generic drug ceased being distributed, and the corresponding trade or brand name. We do not believe it is necessary to also require prescription status to be reported to FDA and included on the list because such information is easily obtained from product labeling or other publicly available sources if the trade name is known. The information required to be reported under new § 314.81(b)(2)(ii)(b) of the regulations tracks the requirements of section 505(t) of the act and adequately informs the public of the marketing of an authorized generic drug. Thus, we decline to adopt the suggestion to require submission of prescription status information.
(Comment 2) One comment requested that we clarify the contents of the required submission, particularly with regard to distribution data that is required to be submitted under current § 314.81(b)(2)(ii) with the annual report.
(Response) As stated in section II of this document, the information we are requiring be submitted separately for authorized generic drugs is the date each authorized generic drug entered the market, the date each authorized generic drug ceased being distributed, and the corresponding trade or brand name. Current § 314.81(b)(2)(ii) requires that distribution data about a drug product marketed under an approved NDA be submitted with the annual report. In the codified of this final rule, § 314.81(b)(2)(ii) is renumbered as § 314.81(b)(2)(ii)(a), but otherwise remains unchanged. Distribution data is not required to be separately submitted under this rule for inclusion on the authorized generic drug list.
(Response) The purpose of this rule is to facilitate FDA's obligation to accurately report a complete list of all authorized generic drugs included in annual reports and to update the list in a timely fashion. To fulfill our obligation, we need ready access to the required information. Therefore, in this final rule, we are requiring that the section 505(t) of the act information be separately sent to us, as proposed. However, in response to the comments, we have modified the language in § 314.81(b)(2)(ii)(b) to provide that the authorized generics information may also be submitted to FDA using e-mail, in lieu of sending the information by regular mail or courier. FDA believes this will provide an alternative method of submission that may be more convenient for some sponsors. We encourage sponsors that currently elect to submit their annual reports in electronic format to continue to do so. At such time that electronic submission of annual reports is mandated by FDA and FDA develops the capability to readily retrieve information it needs to comply with section 505(t) of the act, separate submission of the authorized generic information will no longer be necessary, and the language in § 314.81(b)(2)(ii)(b) of the codified has been clarified to reflect this. Until electronic submission of annual reports is required and FDA can readily retrieve the authorized generics information from the annual reports database, sponsors must submit the authorized generics information separately by regular mail or e-mail (regardless of Start Printed Page 37166what format the sponsor currently uses to submit its annual report).
(Response) We have adopted an effective date of 6 months after publication of this final rule. We believe that 6 months will allow time for advance planning, revision of operating procedures, and any review of historical records that would be necessary to collect the required information on marketing of authorized generic drugs since 1999 that must be reported under new § 314.81(b)(ii)(b) of the regulations. Because we have adopted an effective date that permits adequate time for manufacturers/sponsors to collect and report information on both currently marketed authorized generic drugs and authorized generic drugs marketed since 1999, it is not necessary to adopt the two-stage reporting process recommended by the commenter. Accordingly, we decline to revise the final rule to adopt such a process.
Description: This rulemaking requires the holder of an NDA to notify the agency if an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central contact point. We are taking this action as part of our implementation of FDAAA, which Start Printed Page 37167requires that FDA publish a list of all authorized generic drugs included in an annual report after January 1, 1999, and that the agency update the list quarterly. We initially published this list on June 27, 2008, on the Internet and notified relevant Federal agencies that the list was published, and we will continue to update it.
Table 1.—Estimated Annual Reporting Burden121 CFR 314.81(b)(2)(ii)(b)Number of respondentsAnnual frequency per responseTotal annual responsesHours per responseTotal hoursAuthorized generic drug information in the first annual report submitted after the implementation of § 314.81(b)(2)(ii)(b)606.74001 hour400Authorized generic drug information submitted in each subsequent annual report606.740015 minutes100The submission of a copy of that portion of each annual report containing authorized generic drug information606.74003 minutes201 There are no capital costs or operating and maintenance costs associated with this collection of information.
During the past several years, FDA has been reviewing annual reports it has received under § 314.81(b)(2) to discern whether an authorized generic drug is being marketed by the NDA holder. Based on information learned from this review and based on the number of annual reports the agency currently receives under § 314.81(b)(2), we estimate that, after the implementation of § 314.81(b)(2)(ii)(b), we will receive approximately 400 annual reports containing the information required under § 314.81(b)(2)(ii)(b) for authorized generic drugs that were marketed during the time period covered by an annual report submitted after January 1, 1999. Based on the number of sponsors that currently submit all annual reports, we estimate that approximately 60 sponsors will submit these 400 annual reports with authorized generics. As indicated in table 1 of this document, we are estimating that the same number of annual reports will be submitted each subsequent year from the same number of sponsors containing the information required under § 314.81(b)(2)(ii)(b), and that the same number of copies of that portion of each annual report containing the authorized generic drug information will be submitted from the same number of sponsors. Concerning the hours per response, based on our estimate of 40 hours to prepare each annual report currently submitted under § 314.81(b)(2), we estimate that sponsors will need approximately 1 hour to prepare the information required under § 314.81(b)(2)(ii)(b) for each authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999; approximately 15 minutes to prepare the information required under § 314.81(b)(2)(ii)(b) for each subsequent annual report; and approximately 3 minutes to submit to FDA a copy of that portion of each annual report containing the authorized generic drug information.
Start Amendment Part2. Section 314.3 is amended in paragraph (b) by alphabetically adding the definition for “authorized generic drug” to read as follows:End Amendment Part
Start Amendment Part3. Section 314.81 is amended by redesignating paragraph (b)(2)(ii) asEnd Amendment Part
(b) Authorized generic drugs. If applicable, the date each authorized generic drug (as defined in § 314.3) entered the market, the date each authorized generic drug ceased being distributed, and the corresponding trade or brand name. Each dosage form and/or strength is a different authorized generic drug and should be listed separately. The first annual report submitted on or after January 25, 2010 must include the information listed in this paragraph for any authorized generic drug that was marketed during the time period covered by an annual report submitted after January 1, 1999. If information is included in the annual report with respect to any authorized generic drug, a copy of that portion of the annual report must be sent to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drug Quality Assessment, Bldg. 21, rm. 2562, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, and marked “Authorized Generic Submission” or, by e-mail, to the Authorized Generics electronic mailbox at AuthorizedGenerics@fda.hhs.gov with “Authorized Generic Submission” indicated in the subject line. However, at such time that FDA has required that annual reports be submitted in an electronic format, the information required by this paragraph must be submitted as part of the annual report, in the electronic format specified for submission of annual reports at that time, and not as a separate submission under the preceding sentence in this paragraph.