Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period, 20525-20526 [2023-07187]

Download as PDF Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice published February 13, 2023 (88 FR 9296). Submit either electronic or written comments by May 15, 2023, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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– 2022–D–0112 for ‘‘Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry.’’ Received VerDate Sep<11>2014 21:13 Apr 05, 2023 Jkt 259001 comments 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 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: An Massaro, Office of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD 20993–0002, 301–467–8507; Gerri Baer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD 20993–0002, 240–402–2865; Diane Maloney, Center for Biologics PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 20525 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7242, Silver Spring, MD 20993–0002, 240– 402–8113; and Vasum Peiris, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993–0002, 301–796–6089. SUPPLEMENTARY INFORMATION: In the Federal Register of February 13, 2023, FDA published a notice announcing the availability of a draft guidance for industry entitled ‘‘Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry,’’ and requested comments on the draft guidance. Interested persons were originally given until April 14, 2023, to comment on the document. The Agency has elected to extend the comment period so that all interested parties are able to more thoroughly consider the request for input. FDA is extending the comment period for 30 days, until May 15, 2023. The Agency believes that this 30-day extension allows adequate time for interested persons to submit comments. Dated: April 3, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–07185 Filed 4–5–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–0278] Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ‘‘Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry,’’ which was announced in the Federal Register of January 25, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the draft guidance published SUMMARY: E:\FR\FM\06APN1.SGM 06APN1 20526 Federal Register / Vol. 88, No. 66 / Thursday, April 6, 2023 / Notices January 25, 2023 (88 FR 4797). Submit either electronic or written comments on the draft guidance by May 8, 2023, to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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– 2022–D–0278 for ‘‘Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry.’’ Received comments 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 VerDate Sep<11>2014 21:13 Apr 05, 2023 Jkt 259001 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 information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We will review this copy, including the claimed confidential information, in our 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1700; or Philip Chao, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2023 (88 FR 4797), we published a notice of availability for a draft guidance entitled ‘‘Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry.’’ This action opened a docket with a 60- PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 day comment period to receive comments related to action levels for lead in processed food intended for babies and young children. We have received a request for a 60day extension of the comment period for the draft guidance to provide additional time to provide analytical data. In the interest of balancing the public health importance of establishing action levels for lead in food labeled for babies and young and granting additional time to submit comments before we finalize the draft guidance, we have concluded that it is reasonable to reopen the comment period for 30 days, until May 8, 2023. We are reopening the comment period because the request for an extension of the comment period arrived too late for us to extend the comment period. We believe that an additional 30 days allows adequate time for interested persons to submit comments. Dated: April 3, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–07187 Filed 4–5–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1057] Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.’’ The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages. The draft guidance also explains how FDA communicates information about products in shortage to the public. This SUMMARY: E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20525-20526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07187]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0278]


Action Levels for Lead in Food Intended for Babies and Young 
Children; Draft Guidance for Industry; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the draft guidance entitled ``Action Levels for Lead 
in Food Intended for Babies and Young Children; Draft Guidance for 
Industry,'' which was announced in the Federal Register of January 25, 
2023. We are taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: FDA is reopening the comment period on the draft guidance 
published

[[Page 20526]]

January 25, 2023 (88 FR 4797). Submit either electronic or written 
comments on the draft guidance by May 8, 2023, to ensure that we 
consider your comment on the draft guidance before we begin work on the 
final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2022-D-0278 for ``Action Levels for Lead in Food Intended for 
Babies and Young Children; Draft Guidance for Industry.'' Received 
comments 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 information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1700; or Philip Chao, Center for Food 
Safety and Applied Nutrition, Office of Regulations and Policy (HFS-
024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2023 
(88 FR 4797), we published a notice of availability for a draft 
guidance entitled ``Action Levels for Lead in Food Intended for Babies 
and Young Children; Draft Guidance for Industry.'' This action opened a 
docket with a 60-day comment period to receive comments related to 
action levels for lead in processed food intended for babies and young 
children.
    We have received a request for a 60-day extension of the comment 
period for the draft guidance to provide additional time to provide 
analytical data. In the interest of balancing the public health 
importance of establishing action levels for lead in food labeled for 
babies and young and granting additional time to submit comments before 
we finalize the draft guidance, we have concluded that it is reasonable 
to reopen the comment period for 30 days, until May 8, 2023. We are 
reopening the comment period because the request for an extension of 
the comment period arrived too late for us to extend the comment 
period. We believe that an additional 30 days allows adequate time for 
interested persons to submit comments.

    Dated: April 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07187 Filed 4-5-23; 8:45 am]
BILLING CODE 4164-01-P
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