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, 54898-54899 [2013-21681]

Download as PDF 54898 Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices ACL estimates the burden of this collection of information as follows: Frequency: Based on the budget authorization for that Fiscal Year, ACL publishes, on average, 15 to 20 FOAs annually. Respondents: States, public agencies, private nonprofit agencies, institutions of higher education, and organizations including tribal organizations. Estimated Number of Responses: 350 annually. Total Estimated Burden Hours: 16,800. Dated: August 29, 2013. Kathy Greenlee, Administrator and Assistant Secretary for Aging. [FR Doc. 2013–21654 Filed 9–5–13; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0523] 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 or we) 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 October 7, 2013. SUMMARY: 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 emailed 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@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. ADDRESSES: 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 (Pub. L. 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 § 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. In the Federal Register of May 10, 2013 (78 FR 27404), 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 is 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) Number of responses per respondent 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 0.50 (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. VerDate Mar<15>2010 18:05 Sep 05, 2013 Jkt 229001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Notices Dated: September 3, 2013. Leslie Kux, Assistant Commissioner for Policy. 54899 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2013–21681 Filed 9–5–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0984] BILLING CODE 4160–01–P [Docket No. FDA–2013–N–0297] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prevention of Salmonella Enteritidis in Shell Eggs During Production— Recordkeeping and Registration DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1181] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping Requirements for Medicated Feed Mill License Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Medicated Feed Mill License Application,’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On May 15, 2013, the Agency submitted a proposed collection of information entitled ‘‘Medicated Feed Mill License Application,’’ 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 0910–0337. The approval expires on August 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: September 3, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Prevention of Salmonella Enteritidis in Shell Eggs During Production— Recordkeeping and Registration,’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On May 20, 2013, the Agency submitted a proposed collection of information entitled ‘‘Prevention of Salmonella Enteritidis in Shell Eggs During Production—Recordkeeping and Registration,’’ 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 0910–0660. The approval expires on August 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: September 3, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21680 Filed 9–5–13; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P 18:05 Sep 05, 2013 Jkt 229001 PO 00000 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.’’ This draft guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 5, 2013. Submit either electronic or written comments concerning the proposed collection of information by November 5, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448; or Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets SUMMARY: Notice. [FR Doc. 2013–21679 Filed 9–5–13; 8:45 am] VerDate Mar<15>2010 Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54898-54899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21681]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 or we) 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 October
7, 2013.

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 emailed 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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, 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 (Pub. L. 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.
In the Federal Register of May 10, 2013 (78 FR 27404), 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 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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of authorized generic drug 70 7 490 0.50 (30 minutes)......................... 245
information in each annual report.
Submission of authorized generic drug 20 1 20 1......................................... 20
information on first marketed generics in
an annual report.
Submission of a copy of that portion of each 70 7 490 0.05 (3 minutes).......................... 25
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.

[[Page 54899]]

Dated: September 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21681 Filed 9-5-13; 8:45 am]
BILLING CODE 4160-01-P

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