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, 27404-27405 [2013-11127]

Download as PDF 27404 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices Estimated annual reporting burden on industry is 29 hours as shown in table 1. Industry estimates it takes about 15 minutes (0.25) to submit the application. We estimate 100 original and supplemental applications, and voluntary revocations for a total of 25 hours (100 submissions x 0.25 (15 minutes)). An additional 4 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 28.5 hours for maintaining and retrieving labels as required by 21 CFR 510.305. We estimated 2 minutes (0.03 hour) for each of approximately 950 licensees. Total burden for reporting and recordkeeping would be 57.5 hours. Dated: May 6, 2013. Leslie Kux, Assistant Commissioner for Policy. currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0726. The approval expires on December 31, 2015. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. [FR Doc. 2013–11128 Filed 5–9–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2012–N–0560] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable [Docket No. FDA–2012–N–0145] AGENCY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, ila.mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On June 5, 2012, the Agency submitted a proposed collection of information entitled ‘‘Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:05 May 09, 2013 Jkt 229001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, daniel.gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On February 11, 2013, the Agency submitted a proposed collection of information entitled ‘‘Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0582. The approval expires on April 30, 2016. A SUMMARY: PO 00000 Frm 00041 Fmt 4703 [FR Doc. 2013–11125 Filed 5–9–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2013–11126 Filed 5–9–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 6, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P Dated: May 6, 2013. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration BILLING CODE 4160–01–P copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Sfmt 4703 [Docket No. FDA–2013–N–0523] 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: Food and Drug Administration, HHS. ACTION: Notice. 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 information collection contained in the requirements for reporting information about authorized generic drugs in an annual report. DATES: Submit either electronic or written comments on the collection of information by July 9, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments 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 docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150– SUMMARY: E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices 400B, Rockville, MD 20857, 301–796– 7726, Ila.mizrachi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under 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 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 concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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, under § 314.81(b)(2)(ii)(b) (21 CFR 314.81(b)(2) (ii)(b)), 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 (Public Law 110–85), 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 27405 was published, and we will continue to update it. Based on the number of annual reports the Agency currently receives under § 314.81(b)(2) containing authorized generic drug information, we estimate that we will receive approximately 500 annual reports containing the required information on authorized generic drugs. Based on the number of sponsors that currently submit these annual reports, we estimate that approximately 70 sponsors will submit these 500 annual reports. We estimate that each sponsor will need approximately 30 minutes to include the required information on authorized generic drugs in each annual report. We also estimate that we will receive authorized generic drug information on first marketed generics in approximately 20 annual reports from approximately 20 sponsors, and that each sponsor will need approximately 1 hour to include the required information in each annual report. We also estimate that we will receive a copy of that portion of each annual report containing the authorized generic drug information for approximately 500 annual reports from approximately 70 sponsors, and that each sponsor will need approximately 3 minutes to submit a copy of that portion of each annual report containing the authorized generic drug information. FDA estimates the burden of this collection of information is as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR 314.81(b)(2)(ii)(b) Total annual responses Average burden per response Total hours Submission of authorized generic drug information in each annual report. Submission of authorized generic drug information on first marketed generics in an annual report. Submission of a copy of that portion of each annual report containing authorized generic drug information. 70 7 490 0.5 (30 minutes) ............................ 245 20 1 20 1 ..................................................... 20 70 7 490 0.05 (3 minutes) ............................ 25 Total .............................................. ........................ ........................ ........................ ........................................................ 290 1 There are no capital costs or operating and maintenance costs associated with this collection of information. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: May 6, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–11127 Filed 5–9–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] BILLING CODE 4160–01–P Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 18:05 May 09, 2013 Jkt 229001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committee: To provide advice and E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27404-27405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11127]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]


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: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 information collection 
contained in the requirements for reporting information about 
authorized generic drugs in an annual report.

DATES: Submit either electronic or written comments on the collection 
of information by July 9, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments 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 docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-

[[Page 27405]]

400B, Rockville, MD 20857, 301-796-7726, Ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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 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 concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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, under Sec.  314.81(b)(2)(ii)(b) 
(21 CFR 314.81(b)(2) (ii)(b)), 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 (Public Law 110-85), 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.
    Based on the number of annual reports the Agency currently receives 
under Sec.  314.81(b)(2) containing authorized generic drug 
information, we estimate that we will receive approximately 500 annual 
reports containing the required information on authorized generic 
drugs. Based on the number of sponsors that currently submit these 
annual reports, we estimate that approximately 70 sponsors will submit 
these 500 annual reports. We estimate that each sponsor will need 
approximately 30 minutes to include the required information on 
authorized generic drugs in each annual report.
    We also estimate that we will receive authorized generic drug 
information on first marketed generics in approximately 20 annual 
reports from approximately 20 sponsors, and that each sponsor will need 
approximately 1 hour to include the required information in each annual 
report.
    We also estimate that we will receive a copy of that portion of 
each annual report containing the authorized generic drug information 
for approximately 500 annual reports from approximately 70 sponsors, 
and that each sponsor will need approximately 3 minutes to submit a 
copy of that portion of each annual report containing the authorized 
generic drug information.
    FDA estimates the burden of this collection of information is as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
  21 CFR 314.81(b)(2)(ii)(b)       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Submission of authorized                    70               7             490  0.5 (30 minutes)             245
 generic drug information in
 each annual report.
Submission of authorized                    20               1              20  1...............              20
 generic drug information on
 first marketed generics in an
 annual report.
Submission of a copy of that                70               7             490  0.05 (3 minutes)              25
 portion of each annual report
 containing authorized generic
 drug information.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             290
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11127 Filed 5-9-13; 8:45 am]
BILLING CODE 4160-01-P
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