81 FR 13804 - Final Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 50 (March 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 50 (March 15, 2016)
| Page Range | 13804-13805 | |
| FR Document | 2016-05720 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Pages 13804-13805] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05720] ----------------------------------------------------------------------- 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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)) (http://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 (http://www.thefederalregister.org/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 http://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
![13804 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
Substances Prohibited From Use in distribute products that contain, or may processes, and then to help inspection
Animal Food or Feed; Animal Proteins contain, protein derived from personnel confirm that the firm is
Prohibited in Ruminant Feed—21 CFR mammalian tissue, and feeds made from operating in compliance with the
589.2000(e)(1)(iv) OMB Control Number such products. regulation. Inspection personnel will
0910–0339—Extension Specifically, this regulation requires evaluate the written procedure and
renderers, feed manufacturers, and confirm it is being followed when they
This information collection was others involved in feed and feed are conducting an inspection.
established because epidemiological ingredient manufacturing and These written procedures must be
evidence gathered in the United distribution to maintain written maintained as long as the facility is
Kingdom suggested that bovine procedures specifying the cleanout operating in a manner that necessitates
spongiform encephalopathy (BSE), a procedures or other means, and the record, and if the facility makes
progressively degenerative central specifying the procedures for separating changes to an applicable procedure or
nervous system disease, is spread to products that contain or may contain process the record must be updated.
ruminant animals by feeding protein protein derived from mammalian tissue Written procedures required by this
derived from ruminants infected with from all other protein products from the section shall be made available for
BSE. This regulation places general time of receipt until the time of inspection and copying by FDA.
requirements on persons that shipment. These written procedures are FDA estimates the burden of this
manufacture, blend, process, and intended to help the firm formalize their collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section; activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
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 authorization of the Biosimilar User Fee public, submit the comment as a
of recordkeepers on inspectional data, Act of 2012 (BsUFA), which enables written/paper submission and in the
which reflect a decline in the number of FDA to collect user fees for the review manner detailed (see ‘‘Written/Paper
recordkeepers. We attribute this decline of biosimilar biological applications for Submissions’’ and ‘‘Instructions’’).
to a reduction in the number of firms fiscal years 2013 to 2017. This notice
Written/Paper Submissions
handling animal protein for use in solicits comments on the final report.
animal feed. DATES: The report will be released on or Submit written/paper submissions as
Dated: March 9, 2016. before March 17, 2016. Submit either follows:
electronic or written comments on the • Mail/Hand delivery/Courier (for
Leslie Kux,
final report by April 14, 2016. written/paper submissions): Division of
Associate Commissioner for Policy.
ADDRESSES: You may submit comments Dockets Management (HFA–305), Food
[FR Doc. 2016–05716 Filed 3–14–16; 8:45 am] and Drug Administration, 5630 Fishers
as follows:
BILLING CODE 4164–01–P Lane, Rm. 1061, Rockville, MD 20852.
Electronic Submissions • For written/paper comments
Submit electronic comments in the submitted to the Division of Dockets
DEPARTMENT OF HEALTH AND Management, FDA will post your
HUMAN SERVICES following way:
• Federal eRulemaking Portal: http:// comment, as well as any attachments,
Food and Drug Administration www.regulations.gov. Follow the except for information submitted,
instructions for submitting comments. marked, and identified, as confidential,
[Docket No. FDA–2016–N–0781] Comments submitted electronically, if submitted as detailed in
including attachments, to http:// ‘‘Instructions.’’
Final Results of Study of Workload www.regulations.gov will be posted to Instructions: All submissions received
Volume and Full Costs Associated the docket unchanged. Because your must include the Docket No. FDA–
With Review of Biosimilar Biological comment will be made public, you are 2016–N–0781 for ‘‘Final Results of the
Product Applications solely responsible for ensuring that your Study of Workload Volume and Full
AGENCY: Food and Drug Administration, comment does not include any Costs Associated With Review of
HHS. confidential information that you or a Biosimilar Biological Product
ACTION: Notice; request for comments. third party may not wish to be posted, Applications.’’ Received comments will
such as medical information, your or be placed in the docket and, except for
SUMMARY: The Food and Drug anyone else’s Social Security number, or those submitted as ‘‘Confidential
Administration (FDA or Agency) is confidential business information, such Submissions,’’ publicly viewable at
announcing an opportunity for public as a manufacturing process. Please note http://www.regulations.gov or at the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
comment on the final results of a study that if you include your name, contact Division of Dockets Management
of the workload volume and full costs information, or other information that between 9 a.m. and 4 p.m., Monday
associated with the process for the identifies you in the body of your through Friday.
review of biosimilar biological product comments, that information will be • Confidential Submissions—To
applications (final report). This study posted on http://www.regulations.gov. submit a comment with confidential
was conducted by an independent • If you want to submit a comment information that you do not wish to be
consulting firm, and it fulfills FDA’s with confidential information that you made publicly available, submit your
statutory requirement under the first do not wish to be made available to the comments only as a written/paper
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![Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13805
submission. You should submit two September 2017. FDA uses these fees to Management and Budget (OMB) for
copies total. One copy will include the expedite the review process for review and approval. Comments
information you claim to be confidential biosimilar biological products. submitted during the first public review
with a heading or cover note that states Biosimilar biological products represent of this ICR will be provided to OMB.
‘‘THIS DOCUMENT CONTAINS an important public health benefit, with OMB will accept further comments from
CONFIDENTIAL INFORMATION.’’ The the potential to offer life-saving or life- the public during the review and
Agency will review this copy, including altering benefits at reduced cost to the approval period.
the claimed confidential information, in patient. BsUFA facilitates the DATES: Comments on this ICR should be
its consideration of comments. The development of safe and effective received no later than April 14, 2016.
second copy, which will have the biosimilar products for the American ADDRESSES: Submit your comments,
claimed confidential information public. including the Information Collection
redacted/blacked out, will be available As part of BsUFA, FDA is required to Request Title, to the desk officer for
for public viewing and posted on http:// contract with an independent HRSA, either by email to OIRA_
www.regulations.gov. Submit both accounting or consulting firm to study submission@omb.eop.gov or by fax to
copies to the Division of Dockets the workload volume and full costs 202–395–5806.
Management. If you do not wish your associated with the process for the FOR FURTHER INFORMATION CONTACT: To
name and contact information to be review of biosimilar biological product request a copy of the clearance requests
made publicly available, you can applications. This notice solicits submitted to OMB for review, email the
provide this information on the cover comments on the final report. The final HRSA Information Collection Clearance
sheet and not in the body of your report is described in section 744I(d) of Officer at paperwork@hrsa.gov or call
comments and you must identify this the FD&C Act (21 U.S.C. 379j–53(d)) (301) 443–1984.
information as ‘‘confidential.’’ Any (http://uscode.house.gov/
SUPPLEMENTARY INFORMATION:
information marked as ‘‘confidential’’ view.xhtml?req=granuleid:U.S.C.-
Information Collection Request Title:
will not be disclosed except in prelim-title21-section379j-
Maternal and Child Health Bureau
accordance with 21 CFR 10.20 and other 53&num=0&edition=prelim), as
Performance Measures for Discretionary
applicable disclosure law. For more amended by the Food and Drug
Grants
information about FDA’s posting of Administration Safety and Innovation OMB No.: 0915–0298—Revision
comments to public dockets, see 80 FR Act enacted in 2012 (http:// Abstract: The Maternal and Child
56469, September 18, 2015, or access www.gpo.gov/fdsys/pkg/PLAW- Health Bureau’s (MCHB) Discretionary
the information at: http://www.fda.gov/ 112publ144/pdf/PLAW- Grant Information System (DGIS)
regulatoryinformation/dockets/ 112publ144.pdf). (FDA has verified the electronically captures performance
default.htm. Web site addresses, as of the date this measure, program, financial, and
Docket: For access to the docket to document publishes in the Federal abstract data, and products and
read background documents or the Register, but Web sites are subject to publications about these discretionary
electronic and written/paper comments change over time.) grants from the grantees. The data
received, go to http:// II. Electronic Access collected are used by MCHB project
www.regulations.gov and insert the officers to monitor and assess grantee
docket number, found in brackets in the The final report can be accessed at
performance as well as assist in
heading of this document, into the http://www.fda.gov/ForIndustry/
monitoring and evaluating MCHB’s
‘‘Search’’ box and follow the prompts UserFees/BiosimilarUserFeeActBsUFA/
programs.
and/or go to the Division of Dockets ucm459682.htm.
Need and Proposed Use of the
Management, 5630 Fishers Lane, Rm. Dated: March 9, 2016. Information: The Health Resources and
1061, Rockville, MD 20852. Leslie Kux, Services Administration (HRSA)
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. proposes to continue using reporting
Mark Ascione, Center for Drug [FR Doc. 2016–05720 Filed 3–14–16; 8:45 am] requirements for grant programs
Evaluation and Research, Food and BILLING CODE 4164–01–P administered by MCHB, including
Drug Administration, 10903 New national performance measures as
Hampshire Ave., Bldg. 51, Rm. 1150, previously approved by OMB, and in
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND accordance with the ‘‘Government
796–7652, FAX: 301–847–8443. HUMAN SERVICES Performance and Results Act (GPRA) of
SUPPLEMENTARY INFORMATION: 1993’’ (Pub. L. 103–62). This Act
Health Resources and Services requires the establishment of
I. Background Administration measurable goals for Federal Programs
The Patient Protection and Affordable that can be reported as part of the
Care Act of 2010 (Pub. L. 111–148) Agency Information Collection budgetary process, thus linking funding
amended the Public Health Service Act Activities: Submission to OMB for decisions with performance.
to create an abbreviated licensure Review and Approval; Public Comment Performance measures for MCHB
pathway for biological products that are Request discretionary grants were initially
demonstrated to be ‘‘biosimilar’’ to or AGENCY: Health Resources and Services approved in January 2003. Approval
‘‘interchangeable’’ with an FDA- from OMB is being sought to continue
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Administration, HHS.
licensed biological product. The Federal ACTION: Notice. the use of performance measures for
Food, Drug, and Cosmetic Act (the these grants. The revised performance
FD&C Act), as amended by BsUFA (Title SUMMARY: In compliance with Section measures are categorized by population
IV of the Food and Drug Administration 3507(a)(1)(D) of the Paperwork domains (Adolescent Health, Child
Safety and Innovation Act, Pub. L. 112– Reduction Act of 1995, the Health Health, Children with Special Health
114), authorizes FDA to assess and Resources and Services Administration Care Needs, Lifecourse/Crosscutting,
collect fees for biosimilar biological (HRSA) has submitted an Information Maternal/Women Health, and Perinatal/
products from October 2012 through Collection Request (ICR) to the Office of Infant Health) consistent with Title V,
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Document Created: 2016-03-15 04:06:48
Document Modified: 2016-03-15 04:06:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for comments. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 13804 |
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