80 FR 63231 - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 201 (October 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 201 (October 19, 2015)
| Page Range | 63231-63232 | |
| FR Document | 2015-26438 |
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)] [Notices] [Pages 63231-63232] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26438] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-0235] Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #229 entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.'' The purpose of this document is to provide recommendations to industry relating to study design and describe criteria the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of new animal drugs that are intended to reduce pathogenic Shiga toxin- producing E. coli (STEC) in cattle. DATES: Submit either electronic or written comments on Agency guidances at any time. 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. [[Page 63232]] 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-2015-D-0235 for ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle; Guidance for Industry; Availability.'' 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. Submit written requests for single copies of this guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Joshua R. Hayes, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0585, joshua.hayes@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 24, 2015 (80 FR 9731), FDA published a notice of availability for a draft guidance entitled ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle'' giving interested persons until April 27, 2015, to comment on the draft guidance. FDA received one comment on the draft guidance. An editorial change to improve clarity was made in finalizing this guidance document. The guidance announced in this notice finalizes the guidance dated February 2015. The guidance discusses general considerations regarding the development of protocols, study conduct, animal welfare, substantial evidence of effectiveness, experimental parameters, nutritional content of experimental diets, and the assessment of drug concentrations in experimental diets. It also discusses the studies and analyses CVM recommends for sponsors to substantiate the effectiveness of pathogenic STEC reduction drugs. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: October 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26438 Filed 10-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices 63231
(the FD&C Act) (21 U.S.C. 360c), FDA assurance of the safety and effectiveness detection of specific novel influenza A
evaluated an application for an in vitro of that device and similar future viruses will collect this information,
diagnostic device for detection of devices. The new classification was compare them with the primer/probe
influenza subtype H5 (Asian lineage), codified in 21 CFR 866.3332, a sequences in their devices, and
commonly known as avian flu. FDA regulation that describes the new incorporate the result of these analyses
concluded that this device is properly classification for reagents for detection into their quality management system,
classified into class II in accordance of specific novel influenza A viruses as required by 21 CFR 820.100(a)(1).
with section 513(a)(1)(B) of the FD&C and sets forth the special controls that These analyses will be evaluated against
Act, because it is a device for which the help to provide a reasonable assurance the device design validation and risk
general controls by themselves are of the safety and effectiveness of devices analysis required by 21 CFR 820.30(g) to
insufficient to provide reasonable classified under that regulation. The determine if any design changes may be
assurance of the safety and effectiveness regulation refers to the special controls necessary.
of the device, but there is sufficient guidance document entitled ‘‘Class II FDA estimates that 10 respondents
information to establish special controls Special Controls Guidance Document: will be affected annually. Each
to provide such assurance. The statute Reagents for Detection of Specific Novel respondent will collect this information
permits FDA to establish as special Influenza A Viruses,’’ which provides twice per year; each response is
controls many different things, recommendations for measures to help estimated to take 15 hours. This results
including postmarket surveillance, provide a reasonable assurance of safety in a total data collection burden of 300
development and dissemination of and effectiveness for these reagents. The hours.
guidance recommendations, and ‘‘other guidance document recommends that The guidance also refers to previously
appropriate actions as the Secretary sponsors obtain and analyze postmarket approved information collections found
deems necessary’’ (section 513(a)(1)(B) data to ensure the continued reliability in FDA regulations. The collections of
of the FD&C Act). This information of their device in detecting the specific information in 21 CFR part 801 have
collection is a measure that FDA novel influenza A virus that it is been approved under OMB control
determined to be necessary to provide intended to detect, particularly given number 0910–0485; the collections of
reasonable assurance of safety and the propensity for influenza viruses to information in 21 CFR part 807 subpart
effectiveness of reagents for detection of mutate and the potential for changes in E have been approved under OMB
specific novel influenza A viruses. disease prevalence over time. As control number 0910–0120; and the
FDA issued an order classifying the updated sequences for novel influenza collections of information in 21 CFR
H5 (Asian lineage) diagnostic device A viruses become available from the part 820 have been approved under
into class II on February 3, 2006 (71 FR World Health Organization, National OMB control number 0910–0073.
14377), establishing the special controls Institutes of Health, and other public FDA estimates the burden of this
necessary to provide reasonable health entities, sponsors of reagents for collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average bur-
No. of records
No. of Total annual den
FD&C Act section per record- Total hours
recordkeepers records per
keeper recordkeeping
513(g) ................................................................................... 10 2 20 15 300
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2015. SUMMARY: The Food and Drug Electronic Submissions
Leslie Kux, Administration (FDA) is announcing the Submit electronic comments in the
Associate Commissioner for Policy. availability of a guidance for industry following way:
[FR Doc. 2015–26441 Filed 10–16–15; 8:45 am] #229 entitled ‘‘Evaluating the • Federal eRulemaking Portal: http://
BILLING CODE 4164–01–P Effectiveness of New Animal Drugs for www.regulations.gov. Follow the
the Reduction of Pathogenic Shiga instructions for submitting comments.
Toxin-Producing E. coli in Cattle.’’ The Comments submitted electronically,
DEPARTMENT OF HEALTH AND purpose of this document is to provide including attachments, to http://
HUMAN SERVICES recommendations to industry relating to www.regulations.gov will be posted to
study design and describe criteria the the docket unchanged. Because your
Food and Drug Administration Center for Veterinary Medicine (CVM) comment will be made public, you are
thinks are the most appropriate for the solely responsible for ensuring that your
[Docket No. FDA–2015–D–0235] evaluation of the effectiveness of new comment does not include any
animal drugs that are intended to reduce confidential information that you or a
Evaluating the Effectiveness of New pathogenic Shiga toxin-producing E. third party may not wish to be posted,
Animal Drugs for the Reduction of such as medical information, your or
asabaliauskas on DSK5VPTVN1PROD with NOTICES
coli (STEC) in cattle.
Pathogenic Shiga Toxin-Producing anyone else’s Social Security number, or
Escherichia coli in Cattle; Guidance for DATES: Submit either electronic or confidential business information, such
Industry; Availability written comments on Agency guidances as a manufacturing process. Please note
at any time. that if you include your name, contact
AGENCY: Food and Drug Administration, information, or other information that
HHS. ADDRESSES: You may submit comments identifies you in the body of your
as follows: comments, that information will be
ACTION: Notice.
posted on http://www.regulations.gov.
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![63232 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
• If you want to submit a comment applicable disclosure law. For more II. Significance of Guidance
with confidential information that you information about FDA’s posting of This level 1 guidance is being issued
do not wish to be made available to the comments to public dockets, see 80 FR consistent with FDA’s good guidance
public, submit the comment as a 56469, September 18, 2015, or access practices regulation (21 CFR 10.115).
written/paper submission and in the the information at: http://www.fda.gov/ The guidance represents the current
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ thinking of FDA on ‘‘Evaluating the
Submissions’’ and ‘‘Instructions’’). default.htm. Effectiveness of New Animal Drugs for
Written/Paper Submissions Docket: For access to the docket to the Reduction of Pathogenic Shiga
Submit written/paper submissions as read background documents or the Toxin-Producing E. coli in Cattle.’’ It
follows: electronic and written/paper comments does not establish any rights for any
• Mail/Hand delivery/Courier (for received, go to http:// person and is not binding on FDA or the
written/paper submissions): Division of www.regulations.gov and insert the public. You can use an alternative
Dockets Management (HFA–305), Food docket number, found in brackets in the approach if it satisfies the requirements
and Drug Administration, 5630 Fishers heading of this document, into the of applicable statutes and regulations.
Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts III. Paperwork Reduction Act of 1995
• For written/paper comments and/or go to the Division of Dockets
submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. This guidance refers to previously
Management, FDA will post your 1061, Rockville, MD 20852. approved collections of information
comment, as well as any attachments, found in FDA regulations. These
Submit written requests for single collections of information are subject to
except for information submitted,
copies of this guidance to the Policy and review by the Office of Management and
marked and identified, as confidential,
Regulations Staff (HFV–6), Center for Budget (OMB) under the Paperwork
if submitted as detailed in
Veterinary Medicine, Food and Drug Reduction Act of 1995 (44 U.S.C. 3501–
‘‘Instructions.’’
Instructions: All submissions received Administration, 7519 Standish Pl., 3520). The collections of information in
must include the Docket No. FDA– Rockville, MD 20855. Send one self- 21 CFR part 514 have been approved
2015–D–0235 for ‘‘Evaluating the addressed adhesive label to assist that under OMB control number 0910–0032.
Effectiveness of New Animal Drugs for office in processing your request. See
the SUPPLEMENTARY INFORMATION section IV. Electronic Access
the Reduction of Pathogenic Shiga
Toxin-Producing E. coli in Cattle; for electronic access to the guidance Persons with access to the Internet
Guidance for Industry; Availability.’’ document. may obtain the draft guidance at either
Received comments will be placed in http://www.fda.gov/AnimalVeterinary/
FOR FURTHER INFORMATION CONTACT:
the docket and, except for those GuidanceComplianceEnforcement/
Joshua R. Hayes, Center for Veterinary GuidanceforIndustry/default.htm or
submitted as ‘‘Confidential
Medicine (HFV–133), Food and Drug http://www.regulations.gov.
Submissions,’’ publicly viewable at
Administration, 7500 Standish Pl.,
http://www.regulations.gov or at the Dated: October 13, 2015.
Rockville, MD 20855, 240–402–0585,
Division of Dockets Management Leslie Kux,
joshua.hayes@fda.hhs.gov.
between 9 a.m. and 4 p.m., Monday Associate Commissioner for Policy.
through Friday. SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–26438 Filed 10–16–15; 8:45 am]
• Confidential Submissions—To
submit a comment with confidential I. Background BILLING CODE 4164–01–P
information that you do not wish to be In the Federal Register of February
made publicly available, submit your 24, 2015 (80 FR 9731), FDA published DEPARTMENT OF HEALTH AND
comments only as a written/paper
a notice of availability for a draft HUMAN SERVICES
submission. You should submit two
guidance entitled ‘‘Evaluating the
copies total. One copy will include the Food and Drug Administration
Effectiveness of New Animal Drugs for
information you claim to be confidential
the Reduction of Pathogenic Shiga [Docket No. FDA–2012–N–0306]
with a heading or cover note that states
Toxin-Producing E. coli in Cattle’’
‘‘THIS DOCUMENT CONTAINS
giving interested persons until April 27, Agency Information Collection
CONFIDENTIAL INFORMATION’’. The
2015, to comment on the draft guidance. Activities; Proposed Collection;
Agency will review this copy, including
FDA received one comment on the draft Comment Request; Administrative
the claimed confidential information, in
guidance. An editorial change to Detention and Banned Medical Devices
its consideration of comments. The
improve clarity was made in finalizing
second copy, which will have the AGENCY: Food and Drug Administration,
claimed confidential information this guidance document. The guidance
HHS.
redacted/blacked out, will be available announced in this notice finalizes the
guidance dated February 2015. ACTION: Notice.
for public viewing and posted on
http://www.regulations.gov. Submit The guidance discusses general SUMMARY: The Food and Drug
both copies to the Division of Dockets considerations regarding the Administration (FDA) is announcing an
Management. If you do not wish your development of protocols, study opportunity for public comment on the
name and contact information to be conduct, animal welfare, substantial proposed collection of certain
asabaliauskas on DSK5VPTVN1PROD with NOTICES
made publicly available, you can evidence of effectiveness, experimental information by the Agency. Under the
provide this information on the cover parameters, nutritional content of Paperwork Reduction Act of 1995 (the
sheet and not in the body of your experimental diets, and the assessment PRA), Federal Agencies are required to
comments and you must identify this of drug concentrations in experimental publish notice in the Federal Register
information as ‘‘confidential.’’ Any diets. It also discusses the studies and concerning each proposed collection of
information marked as ‘‘confidential’’ analyses CVM recommends for sponsors information, including each proposed
will not be disclosed except in to substantiate the effectiveness of extension of an existing collection of
accordance with 21 CFR 10.20 and other pathogenic STEC reduction drugs. information, and to allow 60 days for
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Document Created: 2015-12-15 08:36:13
Document Modified: 2015-12-15 08:36:13
| 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 Agency guidances at any time. | |
| Contact | Joshua R. Hayes, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0585, [email protected] | |
| FR Citation | 80 FR 63231 |
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