Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Withdrawal of Notice of Opportunity for Hearing, 43852-43853 [2020-15245]

Download as PDF 43852 Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project National Survey of Community-Based Survey of Supports for Healthy Eating and Active Living (CBS HEAL)—New— National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Currently, little is known about the environmental and policy supports for healthful diets and regular physical activity within a community across the U.S., and how these supports are changing across time. As a result, CDC plans to conduct a survey to address this gap in knowledge. The survey will be administered to a nationally representative sample of 4,417 Healthy Eating and Active Living’’, expiration 1/1/2015). Assessment of policy and environmental supports for healthful eating and physical activity will serve multiple uses. First, the collected data will describe the characteristics of communities that have specific policy and practice supports favorable for healthy diets and regular physical activity and progress since 2014. Second, the collected data will help identify the extent to which communities implement strategies consistent with current national recommendations. Third, local agencies may use the data collected to consider how they compare nationally or with other municipalities of a similar geography, population size, or urban status. Finally, this information can help guide communities and researchers in local efforts to implement and evaluate policies and practices that support healthy behaviors and choices. CDC requests OMB approval for an estimated 1,693 burden hours annually. Participation is voluntary and there are no costs to respondents other than their time. communities. Respondents will be city planners/managers in these communities. Information will be collected about the following topics: Communitywide planning efforts for healthy eating and active living, the built environment and policies that support physical activity, zoning that supports healthy eating and active living, public transportation policies that support healthy eating and active living, other policies and practices that support access to healthy food and healthy eating, and policies that support employee breastfeeding. Data will be collected using a secure, web-based survey data collection system, with telephone and mail follow-up for nonresponse. The proposed survey content and data collection procedures incorporate lessons learned during an initial pilot study (OMB No. 0920–0934, ‘‘Pilot Study of Community-Based Surveillance and Supports for Healthy Eating/Active Living’’, expiration 5/31/ 2013), as well as the 2014 baseline study (OMB control number 0920–1007, ‘‘National Survey of Community Based Policy and Environmental Supports for ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name City or Town Planner or Manager. National Survey of Community-Based Policy and Environmental Supports for Healthy Eating and Active Living. Telephone Non-response Follow-up Contact Script. Total ........................ .............................................................................. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–15657 Filed 7–17–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0832] Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Withdrawal of Notice of Opportunity for Hearing AGENCY: Food and Drug Administration, HHS. Notice of opportunity for hearing; withdrawal. ACTION: VerDate Sep<11>2014 18:30 Jul 17, 2020 Jkt 250001 Fmt 4703 Total burden hours 1 30/60 1,325 4,417 1 5/60 368 ........................ ........................ ........................ 1,693 The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is announcing the withdrawal of a notice of opportunity for a hearing (NOOH), which proposed to withdraw the approved uses of carbadox, a carcinogenic animal drug intended for use in feeds for swine. FDA is publishing a proposed order that, if finalized, will revoke the current approved method for carbadox because it does not satisfy the statutory requirement that there be a method to ensure that no residue of carcinogenic concern remains in the edible tissues of treated swine. If that order is finalized, we intend to publish in the Federal Register an NOOH proposing to withdraw approval of all new animal drug applications for use of carbadox. Frm 00047 Average burden per response (in hours) 2,650 SUMMARY: PO 00000 Number of responses per respondent Sfmt 4703 The NOOH is withdrawn as of July 15, 2020. ADDRESSES: For access to the docket to read background documents or 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–5692, diane.heinz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In an NOOH published in the Federal Register of April 12, 2016 (81 FR 21559; correction 81 FR 23499), we proposed to DATES: E:\FR\FM\20JYN1.SGM 20JYN1 Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Notices withdraw approval of the new animal drug applications (NADAs) for carbadox. That proposed action was based on two grounds. First, new evidence demonstrates that the Delaney Clause in section 512(d)(1)(I) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(d)(1)(I)), which requires that no residue of a carcinogenic drug can be found in any edible portion of the animal after slaughter, applies because the Diethylstilbestrol (DES) Proviso exception is no longer met. The DES Proviso exception allows such an animal drug to be approved if, among other things, no residue of such drug will be found by methods of examination prescribed or approved by the Secretary of Health and Human Services by regulations, in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animals. Second, new evidence demonstrates that carbadox is not shown to be safe under the General Safety Clause (section 512(e)(1)(B) of the FD&C Act). FDA has reviewed information submitted by the drug sponsor, including some studies submitted in response to the April 2016 NOOH, and determined that the current approved method for detecting residues of carcinogenic concern does not meet the requirements of part 500, subpart E (21 CFR part 500, subpart E), to demonstrate that there is ‘‘no residue’’ of carbadox in any food derived by treated animals as required by section 512(d)(1)(I) of the FD&C Act. FDA is withdrawing the April 2016 NOOH, which proposed to withdraw the approved uses of carbadox. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed order that, if finalized, will revoke the current approved method for carbadox that measures quinoxaline-2-carboxylic acid as the marker residue for carbadox. The proposed order is based on the inadequacy of the current approved method to monitor residue of carcinogenic concern in compliance with FDA’s operational definition of ‘‘no residue’’ in part 500, subpart E, and the requirements in section 512(d)(1)(I) of the FD&C Act. If the proposed order to revoke the current approved method is finalized and the approved analytical method is revoked, we intend to publish in the Federal Register an NOOH proposing to withdraw all new animal drug applications for use of carbadox based on the lack of an approved method to demonstrate compliance with part 500, subpart E, and section 512(d)(1)(I) of the FD&C Act. VerDate Sep<11>2014 18:30 Jul 17, 2020 Jkt 250001 Dated: July 9, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15245 Filed 7–17–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0832] Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method AGENCY: Food and Drug Administration, HHS. ACTION: Proposed order. The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. An approved method is required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as implemented by regulation, to show that no residue of carcinogenic concern from a new animal drug persists in any edible tissue or in any food derived from treated animals. The currently approved method measures quinoxaline-2carboxylic acid (QCA) as a marker residue to detect the presence of any residue of carcinogenic concern. CVM is proposing to revoke the approved method for carbadox based on our determination that it is inadequate to monitor residue of carcinogenic concern in compliance with FDA’s operational definition of no residue because there is no established relationship between QCA measured by the approved method and the residue of carcinogenic concern. SUMMARY: Submit either electronic or written comments on the proposed order by September 18, 2020. DATES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 18, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 43853 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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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–0832 for ‘‘Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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 E:\FR\FM\20JYN1.SGM 20JYN1

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[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43852-43853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0832]


Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; 
Withdrawal of Notice of Opportunity for Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity for hearing; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Veterinary 
Medicine (CVM), is announcing the withdrawal of a notice of opportunity 
for a hearing (NOOH), which proposed to withdraw the approved uses of 
carbadox, a carcinogenic animal drug intended for use in feeds for 
swine. FDA is publishing a proposed order that, if finalized, will 
revoke the current approved method for carbadox because it does not 
satisfy the statutory requirement that there be a method to ensure that 
no residue of carcinogenic concern remains in the edible tissues of 
treated swine. If that order is finalized, we intend to publish in the 
Federal Register an NOOH proposing to withdraw approval of all new 
animal drug applications for use of carbadox.

DATES: The NOOH is withdrawn as of July 15, 2020.

ADDRESSES: For access to the docket to read background documents or 
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 Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-5692, [email protected].

SUPPLEMENTARY INFORMATION: In an NOOH published in the Federal Register 
of April 12, 2016 (81 FR 21559; correction 81 FR 23499), we proposed to

[[Page 43853]]

withdraw approval of the new animal drug applications (NADAs) for 
carbadox. That proposed action was based on two grounds. First, new 
evidence demonstrates that the Delaney Clause in section 512(d)(1)(I) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360b(d)(1)(I)), which requires that no residue of a carcinogenic drug 
can be found in any edible portion of the animal after slaughter, 
applies because the Diethylstilbestrol (DES) Proviso exception is no 
longer met. The DES Proviso exception allows such an animal drug to be 
approved if, among other things, no residue of such drug will be found 
by methods of examination prescribed or approved by the Secretary of 
Health and Human Services by regulations, in any edible portion of such 
animal after slaughter or in any food yielded by or derived from the 
living animals. Second, new evidence demonstrates that carbadox is not 
shown to be safe under the General Safety Clause (section 512(e)(1)(B) 
of the FD&C Act). FDA has reviewed information submitted by the drug 
sponsor, including some studies submitted in response to the April 2016 
NOOH, and determined that the current approved method for detecting 
residues of carcinogenic concern does not meet the requirements of part 
500, subpart E (21 CFR part 500, subpart E), to demonstrate that there 
is ``no residue'' of carbadox in any food derived by treated animals as 
required by section 512(d)(1)(I) of the FD&C Act.
    FDA is withdrawing the April 2016 NOOH, which proposed to withdraw 
the approved uses of carbadox. Elsewhere in this issue of the Federal 
Register, FDA is publishing a proposed order that, if finalized, will 
revoke the current approved method for carbadox that measures 
quinoxaline-2-carboxylic acid as the marker residue for carbadox. The 
proposed order is based on the inadequacy of the current approved 
method to monitor residue of carcinogenic concern in compliance with 
FDA's operational definition of ``no residue'' in part 500, subpart E, 
and the requirements in section 512(d)(1)(I) of the FD&C Act. If the 
proposed order to revoke the current approved method is finalized and 
the approved analytical method is revoked, we intend to publish in the 
Federal Register an NOOH proposing to withdraw all new animal drug 
applications for use of carbadox based on the lack of an approved 
method to demonstrate compliance with part 500, subpart E, and section 
512(d)(1)(I) of the FD&C Act.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15245 Filed 7-17-20; 8:45 am]
BILLING CODE 4164-01-P

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