Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792, 4272-4273 [2015-01404]

Download as PDF 4272 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Sexual Abuse Significant Incident Report Form ................................... Assessment of Risk Form ..................................................................... Care Provider Incident Review Form .................................................... Written policies ...................................................................................... Previous misconduct .............................................................................. Background checks ............................................................................... Reporting misconduct of former employees .......................................... Reporting to investigating authorities .................................................... MOUs with investigating authorities ...................................................... Training documentation ......................................................................... Information for UCs ............................................................................... MOUs with reporting entities ................................................................. Grievance procedures ........................................................................... Agreements with local service providers ............................................... Third Party reporting .............................................................................. Disclosure to parent/guardian ................................................................ Disclosure to atty of record ................................................................... Reporting staff, contractors, and volunteers to investigating authorities Annual reports ....................................................................................... Quarterly reports .................................................................................... Other data .............................................................................................. Audit report ............................................................................................ asabaliauskas on DSK5VPTVN1PROD with NOTICES Instrument 2,430 ................ 57,500 .............. 2,430 ................ 120 ................... 7,479 ................ 748 ................... 75 ..................... 2,430 ................ 120 ................... 7,479 ................ 57,500 .............. 120 ................... 120 ................... 120 ................... 73 or more ....... 2,430 ................ 972 ................... 25 ..................... 120 ................... 120 ................... 120 ................... 40 ..................... 1 or more .......... 1 ....................... 1 ....................... 1 ....................... 1 or more .......... 1 or more .......... 1 ....................... 1 or more .......... 2 or more .......... 1 ....................... 1 ....................... 1 ....................... 1 ....................... 1 or more .......... 1 ....................... 1 ....................... 1 ....................... 1 ....................... 1 ....................... 4 ....................... 20 or more ........ 1 ....................... Estimated Total Annual Burden Hours: 34,713. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to VerDate Sep<11>2014 18:01 Jan 26, 2015 Jkt 235001 comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–01372 Filed 1–26–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0194] Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 AGENCY: Food and Drug Administration, HHS. ACTION: 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 in Form FDA 3792, ‘‘Biosimilars User Fee Cover Sheet’’. Frm 00030 Fmt 4703 Total burden hours 0.5 0.17 0.5 2 0.33 0.1 0.33 0.33 0.33 0.17 0.25 0.25 0.5 1 0.25 0.17 0.17 0.25 4 2 0.25 8 1,215 or more. 9,775. 1,215. 240. 2,468. 74.8. 25. 802 or more. 79 or more. 1,271. 14,375. 30. 60. 120. 18 or more. 413. 165. 6. 480. 960. 600. 320. Submit either electronic or written comments on the collection of information by March 30, 2015. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. DATES: 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, SUPPLEMENTARY INFORMATION: Notice. SUMMARY: PO 00000 Average burden hours per response Sfmt 4703 E:\FR\FM\27JAN1.SGM 27JAN1 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 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. Biosimilars User Fee Cover Sheet; Form FDA 3792 (OMB Control Number 0910– 0718)—Extension The Patient Protection and Affordable Care Act (Pub. L. 111–148) contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. Section 351(k) of the PHS Act, added by the BPCI Act, allows a company to submit an application for licensure of a biosimilar or interchangeable biological product. The BPCI Act also amends section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the definition of ‘‘human drug application’’ for the purposes of the prescription drug user fee provisions. The BPCI Act directs FDA to develop recommendations for a biosimilar biological product user fee program for fiscal years 2013 through 2017. FDA’s recommendations for a biosimilar biological product user fee program were submitted to Congress on January 13, 2012. FDA’s biosimilar biological product user fee program requires FDA to assess and collect user fees for certain meetings concerning biosimilar 4273 biological product development (BPD meetings), investigational new drug applications (INDs) intended to support a biosimilar biological product application, and biosimilar biological product applications and supplements. Form FDA 3792, the Biosimilars User Fee Cover Sheet, requests the minimum necessary information to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system. The information collected is used by FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to initiate the administrative screening of biosimilar biological product INDs, applications, and supplements, and to account for and track user fees associated with BPD meetings. Respondents to this collection of information are manufacturers of biosimilar biological product candidates. Based on the number of Form FDA 3792s we have received, we estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA form No. Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Biosimilars User Fee Cover Sheet; Form FDA 3792 .. 20 1 20 0.50 (30 minutes) ... 10 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 21, 2015. 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. 2015–01404 Filed 1–26–15; 8:45 am] BILLING CODE 4164–01–P Fax written comments on the collection of information by February 26, 2015. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. FDA–2014–N–1414] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls Guidance Document: Labeling of Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing SUMMARY: 18:01 Jan 26, 2015 FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver FOR FURTHER INFORMATION CONTACT: Notice. VerDate Sep<11>2014 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 0910–0633. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Jkt 235001 PO 00000 Frm 00031 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: Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300—(OMB Control Number 0910–0633)—Extension Under the Medical Device Amendments of 1976 (Pub. L. 94–295), class II devices were defined as those devices for which there was insufficient information to show that general controls themselves would provide a reasonable assurance of safety and effectiveness but for which there was sufficient information to establish performance standards to provide such assurance. Condoms without spermicidal lubricant containing nonoxynol 9 are E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4272-4273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01404]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0194]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792

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 in 
Form FDA 3792, ``Biosimilars User Fee Cover Sheet''.

DATES: Submit either electronic or written comments on the collection 
of information by March 30, 2015.

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: 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: 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,

[[Page 4273]]

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.

Biosimilars User Fee Cover Sheet; Form FDA 3792 (OMB Control Number 
0910-0718)--Extension

    The Patient Protection and Affordable Care Act (Pub. L. 111-148) 
contains a subtitle called the Biologics Price Competition and 
Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends 
the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other 
statutes to create an abbreviated approval pathway for biological 
products shown to be biosimilar to or interchangeable with an FDA-
licensed reference biological product. Section 351(k) of the PHS Act, 
added by the BPCI Act, allows a company to submit an application for 
licensure of a biosimilar or interchangeable biological product. The 
BPCI Act also amends section 735 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the 
definition of ``human drug application'' for the purposes of the 
prescription drug user fee provisions. The BPCI Act directs FDA to 
develop recommendations for a biosimilar biological product user fee 
program for fiscal years 2013 through 2017. FDA's recommendations for a 
biosimilar biological product user fee program were submitted to 
Congress on January 13, 2012.
    FDA's biosimilar biological product user fee program requires FDA 
to assess and collect user fees for certain meetings concerning 
biosimilar biological product development (BPD meetings), 
investigational new drug applications (INDs) intended to support a 
biosimilar biological product application, and biosimilar biological 
product applications and supplements. Form FDA 3792, the Biosimilars 
User Fee Cover Sheet, requests the minimum necessary information to 
determine the amount of the fee required, and to account for and track 
user fees. The form provides a cross-reference of the fees submitted 
for a submission with the actual submission by using a unique number 
tracking system. The information collected is used by FDA's Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research to initiate the administrative screening of biosimilar 
biological product INDs, applications, and supplements, and to account 
for and track user fees associated with BPD meetings.
    Respondents to this collection of information are manufacturers of 
biosimilar biological product candidates. Based on the number of Form 
FDA 3792s we have received, we estimate the burden of this collection 
of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                FDA form No.                    Number of      responses per     Total annual         Average burden  per response         Total hours
                                               respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilars User Fee Cover Sheet; Form FDA               20                1               20   0.50 (30 minutes)......................              10
 3792.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01404 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P
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