Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0237]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by August 8, 2011.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB,

Attn:

FDA Desk Officer,

Fax:

202-395-7285, or e-mailed to

oira_submission@omb.eop.gov.

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.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792,

Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs—(OMB Control Number 0910-0646)—Extension

In the

Federal Register

of July 28, 2009 (74 FR 37163), FDA published a final rule that required the holder of a new drug application (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.

In the

Federal Register

of April 13, 2011 (76 FR 20677), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden

1

21 CFR 314.81(b)(2)(ii)(

b

)

Number of

respondents

Number of reponses per respondent

Total annual responses

Average

burden per

response (in hours)

2

Total hours

Authorized generic drug information on first marketed generics in an annual report

60

6.7

400

1

400

Authorized generic drug information submitted in each subsequent annual report

60

6.7

400

15/60

100

The submission of a copy of that portion of each annual report containing authorized generic drug information

60

6.7

400

3/60

20

Total

520

1

There are no capital costs or operating and maintenance costs associated with this collection of information.

2

Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format “[number of minutes per response]/60.”

Dated: July 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-17141 Filed 7-7-11; 8:45 am]

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