Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs; Request for Comments; Extension of Comment Period, 48150-48151 [2019-19697]

Download as PDF 48150 Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4069] Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public. DATES: The meeting will be held on October 7, 2019, from 9 a.m. to 2:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, section C), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https:// collaboration.fda.gov/ scienceboard2019/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301–796–4769, rakesh.raghuwanshi@fda.hhs.gov, or FDA Advisory Committee Information jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:27 Sep 11, 2019 Jkt 247001 Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The Science Board will hear a response from the Center for Biologics Evaluation and Research (CBER) to the recommendations made by the Science Board’s review of CBER’s research program. The Science Board will also discuss whether there are any relevant published scientific studies that have become available since the 2011 Foods Advisory Committee meeting that changes the state of knowledge regarding any connection between children’s consumption of foods containing certified color additives and hyperactivity or other behavioral effects. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 30, 2019. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 23, 2019. Time allotted for each presentation may be PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 26, 2019. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Rakesh Raghuwanshi at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–19766 Filed 9–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3019] Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs; Request for Comments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice; request for comments, extension of comment period. ACTION: The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for the request for comments that appeared in the Federal Register of August 9, 2019. In that document, we requested comments on transit times to slaughter, milking frequency, and how SUMMARY: E:\FR\FM\12SEN1.SGM 12SEN1 Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices end users interpret zero-day withdrawal period, or zero-day milk discard times statements found on new animal drug labeling. We are 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 published August 9, 2019 (84 FR 39340). Submit either electronic or written comments by January 6, 2020. ADDRESSES: 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 January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 6, 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. 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’’). jbell on DSK3GLQ082PROD with NOTICES 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. VerDate Sep<11>2014 17:27 Sep 11, 2019 Jkt 247001 • 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– 2019–N–3019 for ‘‘Transit Times to Slaughter Facilities, Milking Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard Times Assigned to New Animal Drugs.’’ 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. • 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 48151 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Charli M. Long-Medrano, Center for Veterinary Medicine (HFV–150), Food and Drug Administration, 7500 Standish Pl., Rm. E340, Rockville, MD 20855, 240–402–0850, Charli.Long-Medrano@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2019, FDA published a request for comments with a 60-day comment period to request comments on transit times to slaughter, milking frequency, and how end users interpret zero-day withdrawal period, or zero-day milk discard time statements found on new animal drug labeling. Comments on interpretation of these labeling statements will help to evaluate if our current approach to assigning zero-day withdrawal periods and zeroday milk discard times to new animal drugs is appropriate. The Agency has received requests for a 90-day extension of the comment period for the request for comments. The requests convey concern that the current 60-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 the request for comments for 90 days, until January 6, 2020. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: September 5, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–19697 Filed 9–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–N–3516, FDA 2019– N–0482, FDA–2012–N–0021, FDA–2018–N– 4042, FDA–2011–D–0597, FDA–2018–N– 4735, FDA–2019–N–0721, FDA–2013–N– 1425, FDA–2018–D–3631, and FDA–2011–D– 0689] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a SUMMARY: E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48150-48151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19697]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3019]


Transit Times to Slaughter Facilities, Milking Frequency, and 
Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard 
Times Assigned to New Animal Drugs; Request for Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments, extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
extending the comment period for the request for comments that appeared 
in the Federal Register of August 9, 2019. In that document, we 
requested comments on transit times to slaughter, milking frequency, 
and how

[[Page 48151]]

end users interpret zero-day withdrawal period, or zero-day milk 
discard times statements found on new animal drug labeling. We are 
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 
published August 9, 2019 (84 FR 39340). Submit either electronic or 
written comments by January 6, 2020.

ADDRESSES: 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 January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 6, 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.

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-2019-N-3019 for ``Transit Times to Slaughter Facilities, Milking 
Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-
Day Milk Discard Times Assigned to New Animal Drugs.'' 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.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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.

FOR FURTHER INFORMATION CONTACT: Charli M. Long-Medrano, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rm. E340, Rockville, MD 20855, 240-402-0850, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2019, 
FDA published a request for comments with a 60-day comment period to 
request comments on transit times to slaughter, milking frequency, and 
how end users interpret zero-day withdrawal period, or zero-day milk 
discard time statements found on new animal drug labeling. Comments on 
interpretation of these labeling statements will help to evaluate if 
our current approach to assigning zero-day withdrawal periods and zero-
day milk discard times to new animal drugs is appropriate.
    The Agency has received requests for a 90-day extension of the 
comment period for the request for comments. The requests convey 
concern that the current 60-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 the request for comments for 90 days, until January 6, 2020. The 
Agency believes that a 90-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
rulemaking on these important issues.

    Dated: September 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19697 Filed 9-11-19; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.