81 FR 13803 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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 | 13803-13804 | |
| FR Document | 2016-05716 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Pages 13803-13804] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05716] [[Page 13803]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0520] Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed 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 extending Office of Management and Budget (OMB) approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed. DATES: Submit either electronic or written comments on the collection of information by May 16, 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-2013-N-0520 for ``Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed.'' 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 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from 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, 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. [[Page 13804]] 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section; activity Number of records per Total annual per Total hours recordkeepers recordkeeper records 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 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
![Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13803
DEPARTMENT OF HEALTH AND public, submit the comment as a regulatoryinformation/dockets/
HUMAN SERVICES written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). read background documents or the
[Docket No. FDA–2013–N–0520] Written/Paper Submissions electronic and written/paper comments
Submit written/paper submissions as received, go to http://
Agency Information Collection www.regulations.gov and insert the
Activities; Proposed Collection; follows:
Comment Request; Substances • Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Ruminant Feed and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
AGENCY: Food and Drug Administration, • For written/paper comments 1061, Rockville, MD 20852.
HHS. submitted to the Division of Dockets
ACTION: Notice. Management, FDA will post your FOR FURTHER INFORMATION CONTACT: FDA
comment, as well as any attachments, PRA Staff, Office of Operations, Food
SUMMARY: The Food and Drug except for information submitted, and Drug Administration, 8455
Administration (FDA) is announcing an marked and identified, as confidential, Colesville Rd., COLE–14526, Silver
opportunity for public comment on the if submitted as detailed in Spring, MD 20993–0002, PRAStaff@
proposed collection of certain ‘‘Instructions.’’ fda.hhs.gov.
information by the Agency. Under the Instructions: All submissions received
Paperwork Reduction Act of 1995 (the must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
PRA), Federal Agencies are required to 2013–N–0520 for ‘‘Substances PRA (44 U.S.C. 3501–3520), Federal
publish notice in the Federal Register Prohibited from Use in Animal Food or Agencies must obtain approval from
concerning each proposed collection of Feed; Animal Proteins Prohibited in OMB for each collection of information
information, including each proposed Ruminant Feed.’’ Received comments they conduct or sponsor. ‘‘Collection of
extension of an existing collection of will be placed in the docket and, except information’’ is defined in 44 U.S.C.
information, and to allow 60 days for for those submitted as ‘‘Confidential 3502(3) and 5 CFR 1320.3(c) and
public comment in response to the Submissions,’’ publicly viewable at includes Agency requests or
notice. This notice solicits comments on http://www.regulations.gov or at the requirements that members of the public
extending Office of Management and Division of Dockets Management submit reports, keep records, or provide
Budget (OMB) approval on the existing between 9 a.m. and 4 p.m., Monday information to a third party. Section
recordkeeping requirements for this through Friday. 3506(c)(2)(A) of the PRA (44 U.S.C.
information collection, regarding animal • Confidential Submissions—To
3506(c)(2)(A)) requires Federal Agencies
proteins prohibited in ruminant feed. submit a comment with confidential
to provide a 60-day notice in the
DATES: Submit either electronic or information that you do not wish to be
made publicly available, submit your Federal Register concerning each
written comments on the collection of proposed collection of information,
information by May 16, 2016. comments only as a written/paper
submission. You should submit two including each proposed extension of an
ADDRESSES: You may submit comments existing collection of information,
as follows: copies total. One copy will include the
information you claim to be confidential before submitting the collection to OMB
Electronic Submissions with a heading or cover note that states for approval. To comply with this
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS requirement, FDA is publishing notice
following way: CONFIDENTIAL INFORMATION.’’ The of the proposed collection of
• Federal eRulemaking Portal: http:// Agency will review this copy, including information set forth in this document.
www.regulations.gov. Follow the the claimed confidential information, in With respect to the following
instructions for submitting comments. its consideration of comments. The collection of information, FDA invites
Comments submitted electronically, second copy, which will have the comments on these topics: (1) Whether
including attachments, to http:// claimed confidential information the proposed collection of information
www.regulations.gov will be posted to redacted/blacked out, will be available is necessary for the proper performance
the docket unchanged. Because your for public viewing and posted on of FDA’s functions, including whether
comment will be made public, you are http://www.regulations.gov. Submit
the information will have practical
solely responsible for ensuring that your both copies to the Division of Dockets
utility; (2) the accuracy of FDA’s
comment does not include any Management. If you do not wish your
estimate of the burden of the proposed
confidential information that you or a name and contact information to be
made publicly available, you can collection of information, including the
third party may not wish to be posted,
provide this information on the cover validity of the methodology and
such as medical information, your or
anyone else’s Social Security number, or sheet and not in the body of your assumptions used; (3) ways to enhance
confidential business information, such comments and you must identify this the quality, utility, and clarity of the
as a manufacturing process. Please note information as ‘‘confidential.’’ Any information to be collected; and (4)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
that if you include your name, contact information marked as ‘‘confidential’’ ways to minimize the burden of the
information, or other information that will not be disclosed except in collection of information on
identifies you in the body of your accordance with 21 CFR 10.20 and other respondents, including through the use
comments, that information will be applicable disclosure law. For more of automated collection techniques,
posted on http://www.regulations.gov. information about FDA’s posting of when appropriate, and other forms of
• If you want to submit a comment comments to public dockets, see 80 FR information technology.
with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
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![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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Document Created: 2016-03-15 04:06:58
Document Modified: 2016-03-15 04:06:58
| 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. | |
| Dates | Submit either electronic or written comments on the collection of information by May 16, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 13803 |
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