80 FR 12486 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 45 (March 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 45 (March 9, 2015)
| Page Range | 12486-12487 | |
| FR Document | 2015-05356 |
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)] [Notices] [Pages 12486-12487] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05356] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0510] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or 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 April 8, 2015. 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 0910-0627. 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, 8455 Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002 [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--21 CFR Part 589 (OMB Control Number 0910-0627--Revision) This regulation prohibits the use of certain cattle origin materials in the food or feed of all animals to help prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle. BSE is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. These measures will further strengthen existing safeguards against BSE. In the Federal Register of November 21, 2014 (79 FR 69493), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received however it did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average Operating and 21 CFR Section 589.2001; Substances prohibited from use Number of records per Total annual burden per Total hours maintenance in animal food or feed recordkeepers recordkeeper records recordkeeper costs -------------------------------------------------------------------------------------------------------------------------------------------------------- 589.2001(c)(2)(vi) and (c)(3)(i)........................ 175 1 175 20 3,500 $59,500 589.2001(c)(2)(ii)...................................... 50 1 50 20 1,000 17,000 589.2001(c)(3)(i)(A).................................... 175 1 175 26 4,550 80,580 ----------------------------------------------------------------------------------------------- Total............................................... .............. .............. .............. .............. 9,050 157,080 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. Description of Respondents for Recordkeeping: Rendering facilities, medicated feed manufacturers, livestock feeders. The Agency's recordkeeping burden estimate was calculated by multiplying the number of recordkeepers times the number of records per recordkeeper to determine the total annual number of records. The total number of annual records were then multiplied by the average burden per recordkeeper to determine the total number of burden hours. [[Page 12487]] Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section 589.2001(f) Number of responses per Total annual Average burden Total hours respondents respondent responses per respondent ---------------------------------------------------------------------------------------------------------------- One-time (initial) burden....... 1 1 1 80 80 Burden from future review....... 1 1 1 26 26 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating costs associated with the collection of information. Description of Respondents for Reporting: The final regulation on BSE (73 FR 22720) included a provision that exempts cattle materials prohibited in animal feed (CMPAF) from designated countries from the prohibition on its use in animal feed. A foreign country seeking this designation will submit a written request to FDA that includes a variety of information about the country's BSE status (Sec. 589.2001(f)). During the past 6 years, FDA received 2 requests from countries to be exempted from CMPAF restrictions. One-Time (Initial) Reporting Burden There is a one-time burden to countries that apply to FDA seeking to be designated as not subject to restrictions applicable to CMPAF. We estimate that each country that applies for an exclusion will spend 80 hours putting information together to submit to FDA. Table 2 row 1 presents the one-time burden for the exclusion. (See final BSE regulation at 73 FR 22754). Recurring Burden Countries that successfully petition FDA to be designated as exempt from certain BSE-related restrictions applicable to animal feed will be subject to future review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries from time-to-time to confirm that their BSE situation and the information submitted by them in support of their original application remains unchanged. We assume it will take FDA and the designated country undergoing a review in the future about one third the time and effort it did when the information was submitted. Table 2 row 2 presents the expected recurring burden. Dated: March 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05356 Filed 3-6-15; 8:45 am] BILLING CODE 4164-01-P
![12486 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
H. Should any provision of these to the privacy policy located here: comments should be identified with the
Official Rules be or become illegal or http://www.ftc.gov/site-information/ OMB control number 0910–0627. Also
unenforceable under applicable Federal privacy-policy. include the FDA docket number found
law, such illegality or unenforceability in brackets in the heading of this
15. Contact Us
shall leave the remainder of these document.
Official Rules unaffected and valid. The Please visit the Contest Web site for
further Contest information and FOR FURTHER INFORMATION CONTACT: FDA
illegal or unenforceable provision may
updates. PRA Staff, Office of Operations, Food
be replaced by the Sponsor with a valid
and Drug Administration, 8455
and enforceable provision that, in the Jessica Rich, Colesville Rd.; COLE–14526, Silver
Sponsor’s sole judgment, comes closest Director, Bureau of Consumer Protection. Spring, MD 20993–0002 PRAStaff@
and best reflects the Sponsor’s intention
[FR Doc. 2015–05442 Filed 3–6–15; 8:45 am] fda.hhs.gov.
in a legal and enforceable manner with
BILLING CODE 6750–01–P
respect to the invalid or unenforceable SUPPLEMENTARY INFORMATION: In
provision. compliance with 44 U.S.C. 3507, FDA
13. Disputes has submitted the following proposed
DEPARTMENT OF HEALTH AND collection of information to OMB for
Subject to the release provisions in HUMAN SERVICES review and clearance.
these Official Rules, Contestant agrees
that: Food and Drug Administration Substances Prohibited From Use in
A. Any and all disputes, claims, and [Docket No. FDA–2011–N–0510] Animal Food or Feed—21 CFR Part 589
causes of action arising out of or (OMB Control Number 0910–0627—
connected with this Contest, any Prizes Agency Information Collection Revision)
awarded, the administration of the Activities; Submission for Office of
This regulation prohibits the use of
Contest, the determination of Winners, Management and Budget Review;
certain cattle origin materials in the
or the construction, validity, Comment Request; Substances
food or feed of all animals to help
interpretation, and enforceability of the Prohibited From Use in Animal Food or
prevent the spread of bovine spongiform
Official Rules shall be resolved Feed
encephalopathy (BSE) in U.S. cattle.
individually; BSE is a progressive and fatal
AGENCY: Food and Drug Administration,
B. any and all disputes, claims, and
HHS. neurological disorder of cattle that
causes of action arising out of or
ACTION: Notice. results from an unconventional
connected with this Contest, any Prizes
transmissible agent. BSE belongs to the
awarded, the administration of the SUMMARY: The Food and Drug family of diseases known as
Contest, the determination of Winners, Administration (FDA) is announcing transmissible spongiform
or the construction, validity, that a proposed collection of encephalopathies (TSEs). All TSEs
interpretation, and enforceability of the information has been submitted to the affect the central nervous system of
Official Rules shall be resolved pursuant Office of Management and Budget infected animals. These measures will
to Federal law; (OMB) for review and clearance under
C. under no circumstances will further strengthen existing safeguards
the Paperwork Reduction Act of 1995. against BSE.
Contestants be entitled to, and
DATES: Fax written comments on the In the Federal Register of November
Contestants hereby waive, all rights to
collection of information by April 8, 21, 2014 (79 FR 69493), FDA published
claim, any punitive, incidental, and
2015. a 60-day notice requesting public
consequential damages and any and all
rights to have damages multiplied or ADDRESSES: To ensure that comments on comment on the proposed collection of
otherwise increased. the information collection are received, information. One comment was received
OMB recommends that written however it did not respond to any of the
14. Privacy comments be faxed to the Office of four information collection topics
The Sponsor may collect personal Information and Regulatory Affairs, solicited and is therefore not addressed
information from the Contestant when OMB, Attn: FDA Desk Officer, FAX: by the Agency.
he or she enters the Contest. Such 202–395–7285, or emailed to oira_ FDA estimates the burden of this
personal information collected is subject submission@omb.eop.gov. All collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section 589.2001; Number of Average Operating and
Number of Total annual
Substances prohibited from use in records per burden per Total hours maintenance
recordkeepers records
animal food or feed recordkeeper recordkeeper costs
589.2001(c)(2)(vi) and (c)(3)(i) ................ 175 1 175 20 3,500 $59,500
589.2001(c)(2)(ii) ...................................... 50 1 50 20 1,000 17,000
589.2001(c)(3)(i)(A) .................................. 175 1 175 26 4,550 80,580
Total .................................................. ........................ ........................ ........................ ........................ 9,050 157,080
1 There are no capital costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
Description of Respondents for The Agency’s recordkeeping burden records. The total number of annual
Recordkeeping: Rendering facilities, estimate was calculated by multiplying records were then multiplied by the
medicated feed manufacturers, livestock the number of recordkeepers times the average burden per recordkeeper to
feeders. number of records per recordkeeper to determine the total number of burden
determine the total annual number of hours.
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![Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12487
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section 589.2001(f) responses per burden per Total hours
respondents responses
respondent respondent
One-time (initial) burden ...................................................... 1 1 1 80 80
Burden from future review ................................................... 1 1 1 26 26
1 There are no capital costs or operating costs associated with the collection of information.
Description of Respondents for DEPARTMENT OF HEALTH AND Emphasis Panel 2015 CTSA Application
Reporting: The final regulation on BSE HUMAN SERVICES Review.
Date: April 15–16, 2015.
(73 FR 22720) included a provision that
National Institutes of Health Time: 8:00 a.m. to 5:00 p.m.
exempts cattle materials prohibited in Agenda: To review and evaluate grant
animal feed (CMPAF) from designated applications.
National Center for Advancing
countries from the prohibition on its use Place: Hilton Washington/Rockville 1750
Translational Sciences; Notice of Rockville Pike, Rockville, MD 20852.
in animal feed. A foreign country
Closed Meetings Contact Person: Guo He Zhang, Ph.D.,
seeking this designation will submit a
MPH, Scientific Review Office, Office of
written request to FDA that includes a Pursuant to section 10(d) of the Grants Management & Scientific Review,
variety of information about the Federal Advisory Committee Act, as National Center for Advancing Translational
country’s BSE status (§ 589.2001(f)). amended (5 U.S.C. App.), notice is Sciences (NCATS) National Institutes of
During the past 6 years, FDA received hereby given of the following meetings. Health, 6701 Democracy Boulevard,
2 requests from countries to be The meetings will be closed to the Democracy 1, Room 1064, Bethesda, MD
public in accordance with the 20892, 301–435–0812, zhanggu@
exempted from CMPAF restrictions.
mail.nih.gov.
provisions set forth in sections
One-Time (Initial) Reporting Burden 552b(c)(4) and 552b(c)(6), title 5 U.S.C., (Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
There is a one-time burden to as amended. The grant applications and Physiology, and Biological Chemistry
countries that apply to FDA seeking to the discussions could disclose Research; 93.350, B–Cooperative Agreements;
be designated as not subject to confidential trade secrets or commercial 93.859, Biomedical Research and Research
property such as patentable material, Training, National Institutes of Health, HHS).
restrictions applicable to CMPAF. We
and personal information concerning Dated: March 3, 2015.
estimate that each country that applies
individuals associated with the grant David Clary,
for an exclusion will spend 80 hours applications, the disclosure of which
putting information together to submit Program Analyst, Office of Federal Advisory
would constitute a clearly unwarranted Committee Policy.
to FDA. Table 2 row 1 presents the one- invasion of personal privacy.
time burden for the exclusion. (See final [FR Doc. 2015–05304 Filed 3–6–15; 8:45 am]
Name of Committee: National Center for
BSE regulation at 73 FR 22754). BILLING CODE 4140–01–P
Advancing Translational Sciences Special
Recurring Burden Emphasis Panel Small Business Innovation
Research (SBIR). DEPARTMENT OF HEALTH AND
Countries that successfully petition Date: March 31, 2015.
HUMAN SERVICES
FDA to be designated as exempt from Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
certain BSE-related restrictions National Institutes of Health
applications.
applicable to animal feed will be subject Place: Bethesda Marriott Suites, 6711
to future review by FDA to ensure that Submission for OMB Review; 30-Day
Democracy Boulevard, Bethesda, MD 20817.
their designation remains appropriate. Contact Person: Rahat Khan, Ph.D.,
Comment Request Surveys and
As part of this process, FDA may ask Scientific Review Officer, Office of Scientific Interviews To Support an Evaluation of
Review, National Center for Advancing the Innovative Molecular Analysis
designated countries from time-to-time
Translational Sciences, 6701 Democracy Technologies (IMAT) Program (NCI)
to confirm that their BSE situation and
Blvd., Rm 1078, Bethesda, MD 20892, 301–
the information submitted by them in SUMMARY: Under the provisions of
894–7319, khanr2@csr.nih.gov.
support of their original application section 3507(a)(1)(D) of the Paperwork
Name of Committee: National Center for
remains unchanged. We assume it will Reduction Act of 1995, the National
Advancing Translational Sciences Special
take FDA and the designated country Emphasis Panel CTSA Meeting 1. Institutes of Health (NIH), has submitted
undergoing a review in the future about Date: April 8–9, 2015. to the Office of Management and Budget
one third the time and effort it did when Time: 8:00 a.m. to 5:00 p.m. (OMB) a request for review and
the information was submitted. Table 2 Agenda: To review and evaluate grant approval of the information collection
row 2 presents the expected recurring applications. listed below. This proposed information
Place: Hilton Washington/Rockville 1750 collection was previously published in
burden. Rockville Pike, Rockville, MD 20852. the Federal Register on December 4,
Dated: March 2, 2015. Contact Person: Carol Lambert, Ph.D., 2014, Vol. 79, Page 72004 and allowed
Acting Deputy Director, Office of Grants
mstockstill on DSK4VPTVN1PROD with NOTICES
Leslie Kux, 60-days for public comment. No public
Management & Scientific Review, National
Associate Commissioner for Policy. Center for Advancing Translational Sciences
comments were received. The purpose
[FR Doc. 2015–05356 Filed 3–6–15; 8:45 am] (NCATS) National Institutes of Health, 6701 of this notice is to allow an additional
BILLING CODE 4164–01–P Democracy Boulevard, Democracy 1, Room 30 days for public comment. The
1076, Bethesda, MD 20892, 301–435–0814, National Cancer Institute (NCI),
lambert@mail.nih.gov. National Institutes of Health, may not
Name of Committee: National Center for conduct or sponsor, and the respondent
Advancing Translational Sciences Special is not required to respond to, an
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Document Created: 2015-12-18 12:05:17
Document Modified: 2015-12-18 12:05:17
| 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 April 8, 2015. | |
| 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 | 80 FR 12486 |
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