Final Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications, 13804-13805 [2016-05720]

Download as PDF 13804 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed—21 CFR 589.2000(e)(1)(iv) OMB Control Number 0910–0339—Extension This information collection was established because epidemiological evidence gathered in the United Kingdom suggested that bovine spongiform encephalopathy (BSE), a progressively degenerative central nervous system disease, is spread to ruminant animals by feeding protein derived from ruminants infected with BSE. This regulation places general requirements on persons that manufacture, blend, process, and distribute products that contain, or may contain, protein derived from mammalian tissue, and feeds made from such products. Specifically, this regulation requires renderers, feed manufacturers, and others involved in feed and feed ingredient manufacturing and distribution to maintain written procedures specifying the cleanout procedures or other means, and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment. These written procedures are intended to help the firm formalize their processes, and then to help inspection personnel confirm that the firm is operating in compliance with the regulation. Inspection personnel will evaluate the written procedure and confirm it is being followed when they are conducting an inspection. These written procedures must be maintained as long as the facility is operating in a manner that necessitates the record, and if the facility makes changes to an applicable procedure or process the record must be updated. Written procedures required by this section shall be made available for inspection and copying by FDA. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR section; activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 589.2000(e)(1)(iv); written procedures ................................ 320 1 320 14 4480 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate of the number of recordkeepers on inspectional data, which reflect a decline in the number of recordkeepers. We attribute this decline to a reduction in the number of firms handling animal protein for use in animal feed. Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05716 Filed 3–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0781] Final Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the final results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (final report). This study was conducted by an independent consulting firm, and it fulfills FDA’s statutory requirement under the first asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the final report. DATES: The report will be released on or before March 17, 2016. Submit either electronic or written comments on the final report by April 14, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–N–0781 for ‘‘Final Results of the Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper E:\FR\FM\15MRN1.SGM 15MRN1 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mark Ascione, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993–0002, 301– 796–7652, FAX: 301–847–8443. SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES I. Background The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148) amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be ‘‘biosimilar’’ to or ‘‘interchangeable’’ with an FDAlicensed biological product. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by BsUFA (Title IV of the Food and Drug Administration Safety and Innovation Act, Pub. L. 112– 114), authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 September 2017. FDA uses these fees to expedite the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or lifealtering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public. As part of BsUFA, FDA is required to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. This notice solicits comments on the final report. The final report is described in section 744I(d) of the FD&C Act (21 U.S.C. 379j–53(d)) (https://uscode.house.gov/ view.xhtml?req=granuleid:U.S.C.prelim-title21-section379j53&num=0&edition=prelim), as amended by the Food and Drug Administration Safety and Innovation Act enacted in 2012 (https:// www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW112publ144.pdf). (FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.) II. Electronic Access The final report can be accessed at https://www.fda.gov/ForIndustry/ UserFees/BiosimilarUserFeeActBsUFA/ ucm459682.htm. Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05720 Filed 3–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 13805 Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than April 14, 2016. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grants OMB No.: 0915–0298—Revision Abstract: The Maternal and Child Health Bureau’s (MCHB) Discretionary Grant Information System (DGIS) electronically captures performance measure, program, financial, and abstract data, and products and publications about these discretionary grants from the grantees. The data collected are used by MCHB project officers to monitor and assess grantee performance as well as assist in monitoring and evaluating MCHB’s programs. Need and Proposed Use of the Information: The Health Resources and Services Administration (HRSA) proposes to continue using reporting requirements for grant programs administered by MCHB, including national performance measures as previously approved by OMB, and in accordance with the ‘‘Government Performance and Results Act (GPRA) of 1993’’ (Pub. L. 103–62). This Act requires the establishment of measurable goals for Federal Programs that can be reported as part of the budgetary process, thus linking funding decisions with performance. Performance measures for MCHB discretionary grants were initially approved in January 2003. Approval from OMB is being sought to continue the use of performance measures for these grants. The revised performance measures are categorized by population domains (Adolescent Health, Child Health, Children with Special Health Care Needs, Lifecourse/Crosscutting, Maternal/Women Health, and Perinatal/ Infant Health) consistent with Title V, E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13804-13805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0781]


Final Results of Study of Workload Volume and Full Costs 
Associated With Review of Biosimilar Biological Product Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the final results of a study of 
the workload volume and full costs associated with the process for the 
review of biosimilar biological product applications (final report). 
This study was conducted by an independent consulting firm, and it 
fulfills FDA's statutory requirement under the first authorization of 
the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to 
collect user fees for the review of biosimilar biological applications 
for fiscal years 2013 to 2017. This notice solicits comments on the 
final report.

DATES: The report will be released on or before March 17, 2016. Submit 
either electronic or written comments on the final report by April 14, 
2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0781 for ``Final Results of the Study of Workload Volume and 
Full Costs Associated With Review of Biosimilar Biological Product 
Applications.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper

[[Page 13805]]

submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mark Ascione, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993-0002, 301-
796-7652, FAX: 301-847-8443.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Patient Protection and Affordable Care Act of 2010 (Pub. L. 
111-148) amended the Public Health Service Act to create an abbreviated 
licensure pathway for biological products that are demonstrated to be 
``biosimilar'' to or ``interchangeable'' with an FDA-licensed 
biological product. The Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as amended by BsUFA (Title IV of the Food and Drug Administration 
Safety and Innovation Act, Pub. L. 112-114), authorizes FDA to assess 
and collect fees for biosimilar biological products from October 2012 
through September 2017. FDA uses these fees to expedite the review 
process for biosimilar biological products. Biosimilar biological 
products represent an important public health benefit, with the 
potential to offer life-saving or life-altering benefits at reduced 
cost to the patient. BsUFA facilitates the development of safe and 
effective biosimilar products for the American public.
    As part of BsUFA, FDA is required to contract with an independent 
accounting or consulting firm to study the workload volume and full 
costs associated with the process for the review of biosimilar 
biological product applications. This notice solicits comments on the 
final report. The final report is described in section 744I(d) of the 
FD&C Act (21 U.S.C. 379j-53(d)) (https://uscode.house.gov/view.xhtml?req=granuleid:U.S.C.-prelim-title21-section379j-53&num=0&edition=prelim), as amended by the Food and Drug 
Administration Safety and Innovation Act enacted in 2012 (https://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf). (FDA 
has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.)

II. Electronic Access

    The final report can be accessed at https://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm459682.htm.

    Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05720 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P
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