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, 40374-40375 [2011-17141]

Download as PDF 40374 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: July 1, 2011. Steven Hanmer, OPRE Reports Clearance Officer. [FR Doc. 2011–16974 Filed 7–7–11; 8:45 am] BILLING CODE 4150–30–M 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. 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 SUMMARY: 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 Number of respondents mstockstill on DSK4VPTVN1PROD with NOTICES 21 CFR 314.81(b)(2)(ii)(b) Authorized generic drug information on first marketed generics in an annual report ............................................ Authorized generic drug information submitted in each subsequent annual report ................................................ The submission of a copy of that portion of each annual report containing authorized generic drug information .... VerDate Mar<15>2010 17:52 Jul 07, 2011 Jkt 223001 PO 00000 Frm 00053 Number of reponses per respondent Total annual responses Average burden per response (in hours) 2 Total hours 60 400 1 400 60 6.7 400 15/60 100 60 Fmt 4703 6.7 6.7 400 3/60 20 Sfmt 4703 E:\FR\FM\08JYN1.SGM 08JYN1 40375 Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Number of reponses per respondent Total annual responses Average burden per response (in hours) 2 ........................ ........................ ........................ ........................ 21 CFR 314.81(b)(2)(ii)(b) Total .............................................................................. Total hours 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. 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. [FR Doc. 2011–17141 Filed 7–7–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0108] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 (the PRA). 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–New and title ‘‘Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability.’’ 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:52 Jul 07, 2011 Jkt 223001 Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability—(OMB Control Number 0910—New) I. Background FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.’’ This revised draft guidance provides recommendations for applicants planning to request waivers or reductions in user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379g and 379h). This revised draft guidance describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act, and the procedures for submitting requests for waivers or reductions and requests for reconsideration and appeal. The revised draft guidance also provides clarification on related issues such as user fee exemptions for orphan drugs. After comments are received and considered, FDA intends to promptly issue a final guidance. This revised 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 user fee waivers and reductions for drug products. 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. Paperwork Reduction Act of 1995 Under the PRA (44 U.S.C. 3501– 3520), Federal Agencies must obtain PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 approval from 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 Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document. 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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. The draft guidance describes how to submit requests for waivers, reductions, and refunds of certain user fees. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reduction requests, and for requests for appeals. We estimate that the total annual number of waiver requests submitted for all of these categories will be 90, submitted by 75 different sponsors. We estimate that the average burden hours for preparation of a submission will total 16 hours. Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information. E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40374-40375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17141]


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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 Sec.  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 Sec.  
314.81(b)(2), we estimate that we will receive approximately 400 annual 
reports containing the information required under Sec.  
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 Sec.  
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 Sec.  
314.81(b)(2), we estimate that sponsors will need approximately 1 hour 
to prepare the information required under Sec.  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 
Sec.  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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   21 CFR 314.81(b)(2)(ii)(b)       respondents    reponses per      responses     response (in     Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
Authorized generic drug                       60             6.7             400               1             400
 information on first marketed
 generics in an annual report...
Authorized generic drug                       60             6.7             400           15/60             100
 information submitted in each
 subsequent annual report.......
The submission of a copy of that              60             6.7             400            3/60              20
 portion of each annual report
 containing authorized generic
 drug information...............
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[[Page 40375]]

 
    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]
BILLING CODE 4160-01-P
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