81 FR 60706 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 171 (September 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 171 (September 2, 2016)
| Page Range | 60706-60707 | |
| FR Document | 2016-21157 |
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)] [Notices] [Pages 60706-60707] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21157] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0520] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 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 October 3, 2016. 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 [email protected]. All comments should be identified with the OMB control number 0910-0339. Also include the FDA 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, 20852, [email protected]. 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. 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 [[Page 60707]] 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. In the Federal Register of March 15, 2016 (81 FR 13803), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment; however, it did not pertain to the information collection. 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 Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 589.2000(e)(1)(iv); written procedures............................. 320 1 320 14 4,480 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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: August 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21157 Filed 9-1-16; 8:45 am] BILLING CODE 4164-01-P
![60706 Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
include the FDA docket number found Abbreviated New Animal Drug animal drug. We use the information
in brackets in the heading of this Applications—Sections (b)(2) and (n)(1) submitted, among other things, to assess
document. of the Federal Food, Drug, and bioequivalence to the originally
Cosmetic Act (21 U.S.C. 360b(b)(2) and approved drug and thus, the safety and
FOR FURTHER INFORMATION CONTACT: FDA (n)(1))—OMB Control Number 0910– effectiveness of the generic new animal
PRA Staff, Office of Operations, Food 0669—Extension drug. We allow applicants to submit a
and Drug Administration, Three White complete ANADA or to submit
Flint North, 10A63, 11601 Landsdown Under section 512(b)(2) of the Federal information in support of an ANADA
St., North Bethesda, MD 20852, Food, Drug, and Cosmetic Act (the for phased review. Applicants may
PRAStaff@fda.hhs.gov. FD&C Act), any person may file an submit Form FDA 356v with a complete
abbreviated new animal drug ANADA or a phased review submission
SUPPLEMENTARY INFORMATION: In application (ANADA) seeking approval to ensure efficient and accurate
compliance with 44 U.S.C. 3507, FDA of a generic copy of an approved new processing of information.
has submitted the following proposed animal drug. The information required In the Federal Register of May 11,
collection of information to OMB for to be submitted as part of an ANADA is 2016 (81 FR 29273), FDA published a
review and clearance. described in section 512(n)(1) of the 60-day notice requesting public
FD&C Act. Among other things, an comment on the proposed collection of
ANADA is required to contain information. No comments were
information to show that the proposed received.
generic drug is bioequivalent to, and has FDA estimates the burden of this
the same labeling as, the approved new collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Total
FDA Number of responses burden Total
FD&C Act sections 512(b)(2) and (n)(1) annual
Form respondents per per hours
responses
respondent response
ANADA ................................................................................. 356v ....... 18 1 18 159 2,862
Phased Review with Administrative ANADA ....................... 356v ....... 3 5 15 31.8 477
Total .............................................................................. ................ .................... .................... .................... .................... 3,339
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our DEPARTMENT OF HEALTH AND 202–395–7285, or emailed to oira_
experience with ANADA submissions HUMAN SERVICES submission@omb.eop.gov. All
and requests for phased review. We comments should be identified with the
estimate that we will receive 21 ANADA Food and Drug Administration OMB control number 0910–0339. Also
submissions per year over the next three [Docket No. FDA–2013–N–0520] include the FDA docket number found
years and that three of those in brackets in the heading of this
submissions will request phased review. Agency Information Collection document.
We estimate that each applicant that Activities; Submission for Office of FOR FURTHER INFORMATION CONTACT: FDA
uses the phased review process will Management and Budget Review; PRA Staff, Office of Operations, Food
have approximately five phased reviews Comment Request; Substances and Drug Administration, Three White
per application. We estimate that an Prohibited From Use in Animal Food or Flint North, 10A63, 11601 Landsdown
applicant will take approximately 159 Feed; Animal Proteins Prohibited in St., North Bethesda, 20852, PRAStaff@
Ruminant Feed fda.hhs.gov.
hours to prepare either an ANADA or
the estimated 5 ANADA phased review AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In
submissions and the administrative HHS. compliance with 44 U.S.C. 3507, FDA
ANADA. ACTION: Notice. has submitted the following proposed
Dated: August 26, 2016. collection of information to OMB for
SUMMARY: The Food and Drug review and clearance.
Leslie Kux, Administration (FDA) is announcing
Associate Commissioner for Policy. that a proposed collection of Substances Prohibited From Use in
[FR Doc. 2016–21128 Filed 9–1–16; 8:45 am] information has been submitted to the Animal Food or Feed; Animal Proteins
BILLING CODE 4164–01–P
Office of Management and Budget Prohibited in Ruminant Feed—21 CFR
(OMB) for review and clearance under 589.2000(e)(1)(iv) OMB Control Number
the Paperwork Reduction Act of 1995. 0910–0339—Extension
DATES: Fax written comments on the This information collection was
collection of information by October 3, established because epidemiological
mstockstill on DSK3G9T082PROD with NOTICES
2016. evidence gathered in the United
ADDRESSES: To ensure that comments on Kingdom suggested that bovine
the information collection are received, spongiform encephalopathy (BSE), a
OMB recommends that written progressively degenerative central
comments be faxed to the Office of nervous system disease, is spread to
Information and Regulatory Affairs, ruminant animals by feeding protein
OMB, Attn: FDA Desk Officer, FAX: derived from ruminants infected with
VerDate Sep<11>2014 18:25 Sep 01, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1](https://thefederalregister.org/doc/81_FR_60877/page/1.svg)
![Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices 60707
BSE. This regulation places general protein derived from mammalian tissue changes to an applicable procedure or
requirements on persons that from all other protein products from the process the record must be updated.
manufacture, blend, process, and time of receipt until the time of Written procedures required by this
distribute products that contain, or may shipment. These written procedures are section shall be made available for
contain, protein derived from intended to help the firm formalize their inspection and copying by FDA.
mammalian tissue, and feeds made from processes, and then to help inspection
In the Federal Register of March 15,
such products. personnel confirm that the firm is
Specifically, this regulation requires operating in compliance with the 2016 (81 FR 13803), FDA published a
renderers, feed manufacturers, and regulation. Inspection personnel will 60-day notice requesting public
others involved in feed and feed evaluate the written procedure and comment on the proposed collection of
ingredient manufacturing and confirm it is being followed when they information. FDA received one
distribution to maintain written are conducting an inspection. comment; however, it did not pertain to
procedures specifying the cleanout These written procedures must be the information collection.
procedures or other means, and maintained as long as the facility is FDA estimates the burden of this
specifying the procedures for separating operating in a manner that necessitates collection of information as follows:
products that contain or may contain the record, and if the facility makes
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of Total
21 CFR Section records per annual burden per
recordkeepers hours
recordkeeper records recordkeeping
589.2000(e)(1)(iv); written procedures ................................ 320 1 320 14 4,480
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number notice. This notice solicits comments on Written/Paper Submissions
of recordkeepers on inspectional data, the information collection requirements Submit written/paper submissions as
which reflect a decline in the number of of the Animal Generic Drug User Fee follows:
recordkeepers. We attribute this decline Act (AGDUFA) cover sheet. • Mail/Hand delivery/Courier (for
to a reduction in the number of firms DATES: Submit either electronic or written/paper submission): Division of
handling animal protein for use in written comments on the collection of Dockets Management (HFA–305), Food
animal feed. information by November 1, 2016. and Drug Administration, 5630 Fishers
Dated: August 29, 2016. Lane, Rm. 1061, Rockville, MD 20852.
ADDRESSES: You may submit comments
Leslie Kux, • For written/paper comments
as follows:
Associate Commissioner for Policy. submitted to the Division of Dockets
[FR Doc. 2016–21157 Filed 9–1–16; 8:45 am] Electronic Submissions Management, FDA will post your
comment, as well as any attachments,
BILLING CODE 4164–01–P Submit electronic comments in the except for information submitted,
following way: marked and identified, as confidential,
• Federal eRulemaking Portal: http:// if submitted as detailed in
DEPARTMENT OF HEALTH AND
www.regulations.gov. Follow the ‘‘Instructions.’’
HUMAN SERVICES
instructions for submitting comments. Instructions: All submissions received
Food and Drug Administration Comments submitted electronically, must include the Docket No. FDA–
including attachments, to http:// 2011–N–0655 for ‘‘Animal Generic Drug
[Docket No. FDA–2011–N–0655] www.regulations.gov will be posted to User Fee Act Cover Sheet.’’ Received
the docket unchanged. Because your comments will be placed in the docket
Agency Information Collection comment will be made public, you are
Activities; Proposed Collection; and, except for those submitted as
solely responsible for ensuring that your ‘‘Confidential Submissions,’’ publicly
Comment Request; Animal Generic comment does not include any
Drug User Fee Act Cover Sheet viewable at http://www.regulations.gov
confidential information that you or a or at the Division of Dockets
AGENCY: Food and Drug Administration, third party may not wish to be posted, Management between 9 a.m. and 4 p.m.,
HHS. such as medical information, your or Monday through Friday.
ACTION: Notice. anyone else’s Social Security number, or • Confidential Submissions—To
confidential business information, such submit a comment with confidential
SUMMARY: The Food and Drug as a manufacturing process. Please note information that you do not wish to be
Administration (FDA) is announcing an that if you include your name, contact made publicly available, submit your
opportunity for public comment on the information, or other information that comments only as a written/paper
proposed collection of certain identifies you in the body of your submission. You should submit two
information by the Agency. Under the comments, that information will be copies total. One copy will include the
Paperwork Reduction Act of 1995 (the posted on http://www.regulations.gov. information you claim to be confidential
mstockstill on DSK3G9T082PROD with NOTICES
PRA), Federal Agencies are required to • If you want to submit a comment with a heading or cover note that states
publish notice in the Federal Register with confidential information that you ‘‘THIS DOCUMENT CONTAINS
concerning each proposed collection of do not wish to be made available to the CONFIDENTIAL INFORMATION.’’ The
information, including each proposed public, submit the comment as a Agency will review this copy, including
extension of an existing collection of written/paper submission and in the the claimed confidential information, in
information, and to allow 60 days for manner detailed (see ‘‘Written/Paper its consideration of comments. The
public comment in response to the Submissions’’ and ‘‘Instructions’’). second copy, which will have the
VerDate Sep<11>2014 18:25 Sep 01, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1](https://thefederalregister.org/doc/81_FR_60877/page/2.svg)
Document Created: 2018-02-09 11:55:32
Document Modified: 2018-02-09 11:55:32
| 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 | Fax written comments on the collection of information by October 3, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, 20852, [email protected] | |
| FR Citation | 81 FR 60706 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR