81 FR 85977 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 229 (November 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 229 (November 29, 2016)
| Page Range | 85977-85978 | |
| FR Document | 2016-28660 |
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)] [Notices] [Pages 85977-85978] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28660] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2635] The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for a notice that appeared in the Federal Register of September 14, 2016. In that notice, FDA requested comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the request for comments [[Page 85978]] published September 14, 2016 (81 FR 63187). Submit either electronic or written comments by March 13, 2017. 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-2016-D-2635 for ``Establishing Appropriate Durations of Therapeutic Administration.'' 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: Cindy Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0817, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of September 14, 2016 (81 FR 63187), FDA solicited comments regarding the establishment of appropriate durations of use of antimicrobial drugs of importance to human medicine when administered in the feed or water of food-producing animals for therapeutic purposes with a 90-day comment period. The Agency has received requests for an extension of the comment period. These requests conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the request for comments. FDA has considered the requests and is extending the comment period for 90 additional days, until March 13, 2017. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying FDA's consideration of these important issues. Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28660 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85977
Silver Spring, MD 20993–0002, 240– applicants with an existing PSUR Guidances/default.htm, or http://
402–7911. waiver to substitute the PBRER for the www.fda.gov/BiologicsBloodVaccines/
SUPPLEMENTARY INFORMATION: PSUR without submitting a new waiver GuidanceComplianceRegulatory
request. This guidance describes the Information/Guidances/default.htm.
I. Background steps an applicant should take to submit
III. The Paperwork Reduction Act of
FDA is announcing the availability of the PBRER instead of the PSUR. For
1995
a guidance for industry entitled applicants who do not have a PSUR
‘‘Providing Postmarketing Periodic waiver for their approved application This guidance refers to previously
Safety Reports in the ICH E2C(R2) but would like to submit the PBRER approved collections of information that
Format (Periodic Benefit-Risk instead of the PADER/PAER, this are subject to review by the Office of
Evaluation Report).’’ We are issuing the guidance provides information on how Management and Budget (OMB) under
guidance to describe the conditions to submit a waiver request if they wish the Paperwork Reduction Act of 1995
under which FDA will exercise its to do so. (PRA) (44 U.S.C. 3501–3520). The
waiver authority to permit the holders This guidance describes the content, collections of information related to
of approved new drug applications, format, and submission deadlines submission of waiver requests under
abbreviated new drug applications, and applicants should follow when §§ 314.90(a) and 600.90 have been
biologics license applications submitting the PBRER, as well as U.S.- approved under OMB control numbers
(applicants) to use the reporting format specific appendices that should be 0910–0001 and 0910–0308. The
of the PBRER to submit periodic safety submitted with the PBRER. It also guidance also refers to collections of
reports for their marketed products. The explains how applicants can fulfill information that have been approved
harmonized PBRER is intended to FDA’s annual reporting requirement under OMB control number 0910–0771
promote a consistent approach to while submitting a harmonized PBRER related to providing waiver-related
periodic postmarketing safety reporting that covers a longer reporting interval. materials in accordance with the
among the ICH regions and to enhance In addition, FDA will consider requests guidance.
efficiency by reducing the number of to waive the quarterly reporting Dated: November 22, 2016.
reports generated for submissions to the requirement. Leslie Kux,
regulatory authorities. This guidance finalizes the draft Associate Commissioner for Policy.
FDA’s postmarketing safety reporting guidance for industry entitled
[FR Doc. 2016–28606 Filed 11–28–16; 8:45 am]
regulations require applicants to submit ‘‘Providing Postmarket Periodic Safety
BILLING CODE 4164–01–P
periodic safety reports in the form of a Reports in the ICH E2C(R2) Format
Periodic adverse drug experience report (Periodic Benefit-Risk Evaluation
(PADER) (for drugs) or a Periodic Report),’’ which was announced in the
DEPARTMENT OF HEALTH AND
adverse experience report (PAER) (for Federal Register of April 8, 2013 (78 FR
HUMAN SERVICES
biologics) (21 CFR 314.80(c)(2) and 20926). We reviewed the comments
600.80(c)(2), respectively). FDA has received on the draft guidance and Food and Drug Administration
routinely granted waivers under 21 CFR revised several sections of the guidance
314.90(b) and 600.90(b) permitting in response to comments and questions [Docket No. FDA–2016–D–2635]
applicants to submit an internationally on topics such as the submission of the
The Judicious Use of Medically
harmonized Periodic Safety Update nonexpedited individual case safety
Important Antimicrobial Drugs in Food-
Report (PSUR) prepared in accordance reports, waivers of the quarterly
Producing Animals; Establishing
with ICH E2C (see 62 FR 27470, May 19, reporting requirement, the supplemental
Appropriate Durations of Therapeutic
1997) and 69 FR 5551, February 5, information to be provided with the
Administration; Extension of Comment
2004)) instead of a PADER/PAER under PSUR/PBRER, handling gaps in
Period
conditions stated in the waiver. On reporting with changes to the date of the
November 15, 2012, the ICH Steering data lock point for the reporting AGENCY: Food and Drug Administration,
Committee signed off on the ICH interval, and accepted formats for the HHS.
harmonized guideline ‘‘Periodic Benefit- periodic safety report. In response to ACTION: Notice; extension of comment
Risk Evaluation Report (PBRER) comments, we also clarified the text in period.
E2C(R2)’’ and recommended that the the examples that were given in the
PBRER format be adopted by the ICH draft guidance. SUMMARY: The Food and Drug
regulatory bodies of the three regions. This guidance is being issued Administration (FDA or we) is
Therefore, the new and more consistent with FDA’s good guidance extending the comment period for a
comprehensive report format, the practices regulation (21 CFR 10.115). notice that appeared in the Federal
PBRER, has superseded the PSUR report The guidance represents the current Register of September 14, 2016. In that
format. thinking of FDA on providing notice, FDA requested comments
This guidance provides information postmarketing periodic safety reports in regarding the establishment of
on the steps applicants can take to the ICH E2C(R2) PBRER format. It does appropriately targeted durations of use
submit a PBRER to the FDA in place of not establish any rights for any person of antimicrobial drugs of importance to
a PSUR, PADER, or PAER. The guidance and is not binding on FDA or the public. human medicine (i.e., medically
discusses: (1) Applicants who have a You can use an alternative approach if important antimicrobial drugs) when
waiver for their approved product to they are administered in the feed or
asabaliauskas on DSK3SPTVN1PROD with NOTICES
it satisfies the requirements of the
submit a PSUR instead of a PADER/ applicable statutes and regulations. water of food-producing animals for
PAER and (2) applicants who have not therapeutic purposes. The Agency is
obtained a waiver and are currently II. Electronic Access taking this action in response to
submitting PADERs/PAERs as required Persons with access to the Internet requests for an extension to allow
under FDA regulations. Because the may obtain the document at https:// interested persons additional time to
PBRER has replaced the PSUR as the www.regulations.gov/, http:// submit comments.
ICH E2C harmonized postmarketing www.fda.gov/Drugs/Guidance DATES: FDA is extending the comment
safety report format, FDA is permitting ComplianceRegulatoryInformation/ period on the request for comments
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86206/page/1.svg)
![85978 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
published September 14, 2016 (81 FR made publicly available, submit your FDA has considered the requests and
63187). Submit either electronic or comments only as a written/paper is extending the comment period for 90
written comments by March 13, 2017. submission. You should submit two additional days, until March 13, 2017.
ADDRESSES: You may submit comments copies total. One copy will include the The Agency believes that a 90-day
as follows: information you claim to be confidential extension allows adequate time for
with a heading or cover note that states interested persons to submit comments
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS without significantly delaying FDA’s
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The consideration of these important issues.
following way: Agency will review this copy, including Dated: November 22, 2016.
• Federal eRulemaking Portal: http:// the claimed confidential information, in
www.regulations.gov. Follow the Leslie Kux,
its consideration of comments. The
instructions for submitting comments. Associate Commissioner for Policy.
second copy, which will have the
Comments submitted electronically, claimed confidential information [FR Doc. 2016–28660 Filed 11–28–16; 8:45 am]
including attachments, to http:// redacted/blacked out, will be available BILLING CODE 4164–01–P
www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
comment will be made public, you are copies to the Division of Dockets DEPARTMENT OF HEALTH AND
solely responsible for ensuring that your Management. If you do not wish your HUMAN SERVICES
comment does not include any name and contact information to be Food and Drug Administration
confidential information that you or a made publicly available, you can
third party may not wish to be posted, provide this information on the cover [Docket No. FDA–2010–N–0067]
such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this Pharmaceutical Science and Clinical
confidential business information, such information as ‘‘confidential.’’ Any Pharmacology Advisory Committee;
as a manufacturing process. Please note information marked as ‘‘confidential’’ Establishment of a Public Docket;
that if you include your name, contact will not be disclosed except in Request for Comments; Notice of
information, or other information that accordance with 21 CFR 10.20 and other Meeting
identifies you in the body of your applicable disclosure law. For more AGENCY: Food and Drug Administration,
comments, that information will be information about FDA’s posting of HHS.
posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment ACTION: Notice of public meeting;
56469, September 18, 2015, or access establishment of a public docket;
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the request for comments.
regulatoryinformation/dockets/
public, submit the comment as a default.htm. SUMMARY: The Food and Drug
written/paper submission and in the Docket: For access to the docket to Administration (FDA) announces a
manner detailed (see ‘‘Written/Paper read background documents or the forthcoming public advisory committee
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments meeting of the Pharmaceutical Science
Written/Paper Submissions received, go to http:// and Clinical Pharmacology Advisory
www.regulations.gov and insert the Committee. The general function of the
Submit written/paper submissions as docket number, found in brackets in the committee is to provide advice and
follows: heading of this document, into the
• Mail/Hand delivery/Courier (for recommendations to the Agency on
‘‘Search’’ box and follow the prompts FDA’s regulatory issues. The meeting
written/paper submissions): Division of and/or go to the Division of Dockets
Dockets Management (HFA–305), Food will be open to the public.
Management, 5630 Fishers Lane, Rm. DATES: The meeting will be held on
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. March 15, 2017, from 7:30 a.m. to 3:45
FOR FURTHER INFORMATION CONTACT:
• For written/paper comments p.m.
submitted to the Division of Dockets Cindy Burnsteel, Center for Veterinary ADDRESSES: Omni Shoreham Hotel, the
Management, FDA will post your Medicine (HFV–130), Food and Drug Ballroom, 2500 Calvert St. NW.,
comment, as well as any attachments, Administration, 7500 Standish Pl., Washington, DC 20008. The hotel
except for information submitted, Rockville, MD 20855, 240–402–0817, telephone number is 202–234–0700.
marked and identified, as confidential, cindy.burnsteel@fda.hhs.gov. Answers to commonly asked questions
if submitted as detailed in SUPPLEMENTARY INFORMATION: In the including information regarding special
‘‘Instructions.’’ Federal Register of September 14, 2016 accommodations due to a disability,
Instructions: All submissions received (81 FR 63187), FDA solicited comments visitor parking, and transportation may
must include the Docket No. FDA– regarding the establishment of be accessed at: http://www.fda.gov/
2016–D–2635 for ‘‘Establishing appropriate durations of use of AdvisoryCommittees/
Appropriate Durations of Therapeutic antimicrobial drugs of importance to AboutAdvisoryCommittees/
Administration.’’ Received comments human medicine when administered in ucm408555.htm.
will be placed in the docket and, except the feed or water of food-producing You may submit comments as
for those submitted as ‘‘Confidential animals for therapeutic purposes with a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
follows:
Submissions,’’ publicly viewable at 90-day comment period.
http://www.regulations.gov or at the The Agency has received requests for Electronic Submissions
Division of Dockets Management an extension of the comment period. Submit electronic comments in the
between 9 a.m. and 4 p.m., Monday These requests conveyed concern that following way:
through Friday. the current 90-day comment period does • Federal eRulemaking Portal: http://
• Confidential Submissions—To not allow sufficient time to develop a www.regulations.gov. Follow the
submit a comment with confidential meaningful or thoughtful response to instructions for submitting comments.
information that you do not wish to be the request for comments. Comments submitted electronically,
VerDate Sep<11>2014 17:48 Nov 28, 2016 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/81_FR_86206/page/2.svg)
Document Created: 2016-11-29 00:33:11
Document Modified: 2016-11-29 00:33:11
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period on the request for comments published September 14, 2016 (81 FR 63187). Submit either electronic or written comments by March 13, 2017. | |
| Contact | Cindy Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0817, [email protected] | |
| FR Citation | 81 FR 85977 |
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