Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data, 74727-74728 [2014-29425]

Download as PDF 74727 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours State High Performance Bonus System (HPBS) Transmission File Layouts for HPBS Work Measures ............................................................................ 25 2 12 600 Estimated Total Annual Burden Hours: 600. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information 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: 202–395–7285, Email: OIRA_SUBMISSION@ OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–29421 Filed 12–15–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities (AIDD); Notice of Meeting President’s Committee for People with Intellectual Disabilities (PCPID). ACTION: Notice of meeting. AGENCY: Tuesday, January 27, 2015 from 9:00 a.m. to 4:30 p.m.; and Wednesday, January 28, 2015 from 9:00 a.m. to 4:00 p.m. These meetings will be open to the general public. ADDRESSES: These meetings will be held in the U.S. Department of Health and Human Services/Hubert H. Humphrey mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 19:38 Dec 15, 2014 Jkt 235001 Building located at 200 Independence Avenue SW., Conference Room 505A, Washington, DC 20201. Individuals who would like to participate via conference call may do so by dialing toll-free 888–935–0260, when prompted enter pass code: 3656064. Individuals whose full participation in the meeting will require special accommodations (e.g., sign language interpreting services, assistive listening devices, materials in alternative format such as large print or Braille) should notify Dr. MJ Karimi, PCPID Team Lead, via email at MJ.Karimie@acl.hhs.gov, or via telephone at 202–357–3588, no later than Friday, January 16, 2015. The PCPID will attempt to accommodate requests made after that date, but cannot guarantee the ability to grant requests received after this deadline. All meeting sites are barrier free, consistent with the Americans with Disabilities Act (ADA) and the Federal Advisory Committee Act (FACA). Agenda: The Committee Members will discuss preparation of the PCPID 2015 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. They will also receive presentations from selected experts in the field of Technology for People with Intellectual and Developmental Disabilities. Additional Information: For further information, please contact Dr. MJ Karimi, Team Lead, President’s Committee for People with Intellectual Disabilities, One Massachusetts Avenue NW., Room 4206, Washington, DC 20201. Telephone: 202–357–3588. Fax: 202–205–8037. Email: MJ.Karimie@ acl.hhs.gov SUPPLEMENTARY INFORMATION: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services, through the Administration on Intellectual and Developmental Disabilities, on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. The PCPID Executive Order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies. Dated: December 3, 2014. Aaron Bishop, Commissioner, Administration on Intellectual and Developmental Disabilities (AIDD). [FR Doc. 2014–29417 Filed 12–15–14; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0809] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data 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 January 15, 2015. 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 0910–0630. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: E:\FR\FM\16DEN1.SGM 16DEN1 74728 Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Requirements for Submission of In Vivo Bioequivalence Data—21 CFR parts 314 and 320. SUPPLEMENTARY INFORMATION: OMB Control Number 0910–0630— Extension In the Federal Register of January 16, 2009 (74 FR 2849), the Agency published a final rule revising FDA regulations to require applicants to submit data on all bioequivalence (BE) studies, including studies that do not meet passing bioequivalence criteria, which are performed on a drug product formulation submitted for approval under an abbreviated new drug application (ANDA), or in an amendment or supplement to an ANDA that contains BE studies. In the final rule, FDA amended 314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97 (21 CFR 314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97) to require an ANDA applicant to submit information from all BE studies, both passing and nonpassing, conducted by the applicant on the same drug product formulation as that submitted for approval under an ANDA, amendment, or supplement. In table 1, FDA has estimated the reporting burden associated with each section of this requirement. FDA believes that the majority of additional BE studies will be reported in ANDAs (submitted under 314.94), rather than supplements (reported in 314.97) because it is unlikely than an ANDA holder will conduct BE studies with a drug after the drug has been approved. With respect to the reporting of additional BE studies in amendments (submitted under 314.96), this should also account for a small number of reports because most BE studies will be conducted on a drug prior to the submission of the ANDA and will be reported in the ANDA itself. FDA estimates applicants will require approximately 120 hours of staff time to prepare and submit each additional complete BE study report and approximately 60 hours of staff time for each additional BE summary report. The Agency believes that a complete report will be required approximately 20 percent of the time, while a summary will suffice approximately 80 percent of the time. Based on a weighted-average calculation using the information presented previously in this document, the submission of each additional BE study is expected to take 72 hours of staff time ([120 × 0.2] + [60 × 0.8]). In the Federal Register of June 26, 2014 (79 FR 36320), 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 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 314.94(a)(7) ......................................................................... 314.96(a)(1) ......................................................................... 314.97 .................................................................................. 84 1 1 1 1 1 84 1 1 72 72 72 6,048 72 72 Total .............................................................................. ........................ ........................ ........................ ........................ 6,192 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 10, 2014. Leslie Kux, Associate Commissioner for Policy. 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. [FR Doc. 2014–29425 Filed 12–15–14; 8:45 am] BILLING CODE 4164–01–P Fax written comments on the collection of information by January 15, 2015. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 0910–0284. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2014–N–1409] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing SUMMARY: VerDate Sep<11>2014 19:38 Dec 15, 2014 FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: Notice. Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports on Paper Forms FDA 1932, 1932a, and 2301—21 CFR 514.80; OMB Control Number 0910–0284—Extension Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(l) and 514.80 (21 CFR 514.80) of FDA regulations require applicants of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to report adverse drug experiences and product/manufacturing defects (see 514.80)(b)). Additionally, section 571(e)(3) of the FD&C Act (21 U.S.C. 360ccc(e)(3)) requires that E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74727-74728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0809]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements for 
Submission of Bioequivalence Data

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 January 
15, 2015.

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 0910-0630. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 74728]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.
    Requirements for Submission of In Vivo Bioequivalence Data--21 CFR 
parts 314 and 320.

OMB Control Number 0910-0630--Extension

    In the Federal Register of January 16, 2009 (74 FR 2849), the 
Agency published a final rule revising FDA regulations to require 
applicants to submit data on all bioequivalence (BE) studies, including 
studies that do not meet passing bioequivalence criteria, which are 
performed on a drug product formulation submitted for approval under an 
abbreviated new drug application (ANDA), or in an amendment or 
supplement to an ANDA that contains BE studies. In the final rule, FDA 
amended 314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97 (21 CFR 
314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97) to require an 
ANDA applicant to submit information from all BE studies, both passing 
and nonpassing, conducted by the applicant on the same drug product 
formulation as that submitted for approval under an ANDA, amendment, or 
supplement.
    In table 1, FDA has estimated the reporting burden associated with 
each section of this requirement. FDA believes that the majority of 
additional BE studies will be reported in ANDAs (submitted under 
314.94), rather than supplements (reported in 314.97) because it is 
unlikely than an ANDA holder will conduct BE studies with a drug after 
the drug has been approved. With respect to the reporting of additional 
BE studies in amendments (submitted under 314.96), this should also 
account for a small number of reports because most BE studies will be 
conducted on a drug prior to the submission of the ANDA and will be 
reported in the ANDA itself.
    FDA estimates applicants will require approximately 120 hours of 
staff time to prepare and submit each additional complete BE study 
report and approximately 60 hours of staff time for each additional BE 
summary report. The Agency believes that a complete report will be 
required approximately 20 percent of the time, while a summary will 
suffice approximately 80 percent of the time. Based on a weighted-
average calculation using the information presented previously in this 
document, the submission of each additional BE study is expected to 
take 72 hours of staff time ([120 x 0.2] + [60 x 0.8]).
    In the Federal Register of June 26, 2014 (79 FR 36320), 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
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
314.94(a)(7)....................              84               1              84              72           6,048
314.96(a)(1)....................               1               1               1              72              72
314.97..........................               1               1               1              72              72
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,192
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29425 Filed 12-15-14; 8:45 am]
BILLING CODE 4164-01-P
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