Source: https://www.federalregister.gov/articles/2011/04/13/2011-8820/agency-information-collection-activities-proposed-collection-comment-request-applications-for-food
Timestamp: 2015-10-14 04:02:41
Document Index: 637838426

Matched Legal Cases: ['§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314']

Federal Register | Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Dates: Submit either electronic or written comments on the collection of information by June 13, 2011.
Comments Close: 06/13/2011
-20679 (3 pages)
Docket No. FDA-2011-N-0237
Document Number: 2011-8820
Shorter URL: https://federalregister.gov/a/2011-8820 Action
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements for a New Drug Application (NDA) holder to notify the Agency if an authorized generic drug is marketed by clearly including this information in an easily accessible place in the annual report and by sending a copy of the relevant portion of the annual report to a central contact point in the Agency.
Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs—21 CFR 314.81(b)(2)—(OMB Control Number 0910-0646—Extension)
Submit electronic comments on the collection of information to http://www.regulations.gov. Submit on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the OMB control number 0910-0646. Also include the FDA docket number found in brackets in the heading of this document.
Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr.,P150-400B, Rockville, MD 20850, 301-796-3792, Elizabeth.Berbakos@ fda.hhs.gov.
Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs—21 CFR 314.81(b)(2)—(OMB Control Number 0910-0646—Extension) Back to Top
In the Federal Register of July 28, 2009 (74 FR 37163), FDA published a final rule that required 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 took this action as part of our implementation of the Food and Drug Administration Amendments Act, which requires 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.
During the past several years, FDA has been reviewing annual reports it has received under § 314.81(b)(2) (21 CFR 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 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 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 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.
Number of reponses per
Authorized generic drug information on first marketed generics in an annual report under § 314.81(b)(2)(ii)(b)
[FR Doc. 2011-8820 Filed 4-12-11; 8:45 am]