Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability, 44363-44365 [2023-14691]

Download as PDF Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices • Global Epidemiology, Laboratory, and Surveillance Branch (CWED) • Global Operations and Strategic Management Branch (CWEE) Delegations of Authority All delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization. (Authority: 44 U.S.C. 3101) Robin D. Bailey, Jr., Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2023–14706 Filed 7–11–23; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Income Withholding for Support Order (OMB No.: 0970–0154) Office of Child Support Services, Administration for Children and Families, U.S. Department of Health and Human Services. ACTION: Request for public comments. AGENCY: The Office of Child Support Services (OCSS) (formerly the Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Income Withholding for Support Order (IWO), with minor changes, for an additional three years. The current OMB approval expires September 30, 2023. DATES: Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. You can also obtain copies of the proposed collection of information by emailing infocollection@ acf.hhs.gov. Identify all emailed requests by the title of the information collection. SUPPLEMENTARY INFORMATION: SUMMARY: 44363 Description: The IWO is the required, standard form used to order, and notify, employers and income providers to withhold child support payments from an obligor’s income. It is also used to notify employers and other income providers where to remit the payments, as well as other information needed to correctly withhold payments so that children and families receive the support to which they are entitled. On June 5, 2023, the Administration for Children and Families published a notice in the Federal Register (see 88 FR 36587) to announce a new official name for the former Office of Child Support Enforcement. As a result, all of the IWO instruments underwent revisions to change the ‘‘Office of Child Support Enforcement (OCSE)’’ to ‘‘Office of Child Support Services (OCSS).’’ The IWO form instructions underwent minor edits to clarify the language and OCSS augmented the instructions to include a sample form to improve the respondent’s ability to properly complete the IWO Form. The burden estimates changed to reflect current estimates for the annual number of respondents and responses. Respondents: Courts, private attorneys, custodial parties, or their representatives, employers, and other entities that provide income to noncustodial parents ANNUAL BURDEN ESTIMATES Income withholding order/notice (Courts, private attorneys, custodial parties or their representatives). Income withholding orders/termination of employment/income status (Employers and other income providers). Electronic income withholding orders/termination of employment/income status (Employers and other income providers). Estimated Total Annual Burden Hours: 751,461. Authority: 42 U.S.C. 666(a)(1), (a)(8), and (b)(6). Average burden hours per response 4,694,517 1 5 minutes .... 391,210 1,277,952 8.01 2 minutes .... 341,213 33,746 67.70 30 seconds .. 19,038 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2647] Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2023–14662 Filed 7–11–23; 8:45 am] BILLING CODE P lotter on DSK11XQN23PROD with NOTICES1 Total annual number of responses per respondent Total annual number of respondents Information collection instrument Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: VerDate Sep<11>2014 17:29 Jul 11, 2023 Jkt 259001 PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 Total annual burden hours The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.’’ This draft guidance describes FDA’s current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat inborn errors of metabolism (IEM) when dietary management is a key component of patients’ metabolic control. Optimizing SUMMARY: E:\FR\FM\12JYN1.SGM 12JYN1 44364 Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices and standardizing dietary management in these patients before they enter clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This guidance revises the draft guidance of the same name issued on July 24, 2018. DATES: Submit either electronic or written comments on the draft guidance by September 11, 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 lotter on DSK11XQN23PROD with NOTICES1 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– 2018–D–2647 for ‘‘Inborn Errors of Metabolism That Use Dietary VerDate Sep<11>2014 17:29 Jul 11, 2023 Jkt 259001 Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.’’ 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.’’ 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; or the Office of Communication, PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6304, Silver Spring, MD 20993, 301–796– 1153; or Diane Maloney, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised draft guidance for industry entitled ‘‘Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.’’ This draft guidance describes FDA’s current recommendations for optimizing and standardizing dietary management in clinical trials for the development of drug products intended to treat IEM when dietary management is a key component of patients’ metabolic control. Optimizing and standardizing dietary management in these patients before they enter into clinical trials and during clinical trials is essential to providing an accurate evaluation of the efficacy of new drug products. This draft guidance revises the draft guidance of the same name issued on July 24, 2018 (83 FR 35006). FDA considered comments received on the draft guidance and is reissuing the guidance in draft form. Revisions from the previous draft include: (1) clarification that drug products, including both small molecules and biological products, should be studied in conjunction with dietary management for conditions where dietary management is the current standard of clinical care; (2) clarification that metabolic control may be evaluated by biochemical analytes and clinical assessment as substantiated by current clinical standards of care; (3) clarification that differences in baseline dietary management standards among patients from different countries should be considered and clearly stated in the protocol; and (4) clarification that the E:\FR\FM\12JYN1.SGM 12JYN1 Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices most informative design is a randomized, double-blind clinical trial that includes a concurrent control group (approved drug or placebo). This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.’’ 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 the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB Control No. 0910–0014. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: July 6, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–14691 Filed 7–11–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–2727] 44365 consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by August 28, 2023, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by August 28, 2023. Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2023. All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to ACOMSSubmissions@fda.hhs.gov or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/ scripts/FACTRSPortal/FACTRS/ index.cfm, or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993– 0002. Additional information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. ADDRESSES: Request for Nominations for Individuals and Consumer Organizations for Advisory Committees Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent SUMMARY: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993–0002, 301–796–8220, kimberly.hamilton@fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate contact person listed in table 1. FOR FURTHER INFORMATION CONTACT: TABLE 1—ADVISORY COMMITTEE CONTACTS lotter on DSK11XQN23PROD with NOTICES1 Contact person Committee/panel Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993–0002, 301–796–4769, Rakesh.Raghuwanshi@fda.hhs.gov. Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 20993–0002, 240–402–8006, Prabhakara.Altreya@fda.hhs.gov. Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993– 0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov. She-Chia Jankowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31 Rm. 2438, Silver Spring, MD 20993–0002, 240–402–5343, She-Chia.Jankowski@fda.hhs.gov. VerDate Sep<11>2014 17:29 Jul 11, 2023 Jkt 259001 PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 FDA Science Board Advisory Committee. Allergenic Products Advisory Committee. Anesthetic and Analgesic Drug Products Advisory Committee; Non-Prescription Drugs Advisory Committee. Antimicrobial Drugs Advisory Committee. E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44363-44365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14691]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2647]


Inborn Errors of Metabolism That Use Dietary Management: 
Considerations for Optimizing and Standardizing Diet in Clinical Trials 
for Drug Product Development; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a revised draft guidance for industry entitled 
``Inborn Errors of Metabolism That Use Dietary Management: 
Considerations for Optimizing and Standardizing Diet in Clinical Trials 
for Drug Product Development.'' This draft guidance describes FDA's 
current recommendations for optimizing and standardizing dietary 
management in clinical trials for the development of drug products 
intended to treat inborn errors of metabolism (IEM) when dietary 
management is a key component of patients' metabolic control. 
Optimizing

[[Page 44364]]

and standardizing dietary management in these patients before they 
enter clinical trials and during clinical trials is essential to 
providing an accurate evaluation of the efficacy of new drug products. 
This guidance revises the draft guidance of the same name issued on 
July 24, 2018.

DATES: Submit either electronic or written comments on the draft 
guidance by September 11, 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'').

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-2018-D-2647 for ``Inborn Errors of Metabolism That Use Dietary 
Management: Considerations for Optimizing and Standardizing Diet in 
Clinical Trials for Drug Product Development.'' 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.'' 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-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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6304, Silver Spring, MD 20993, 301-796-
1153; or Diane Maloney, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Inborn Errors of Metabolism That Use Dietary 
Management: Considerations for Optimizing and Standardizing Diet in 
Clinical Trials for Drug Product Development.'' This draft guidance 
describes FDA's current recommendations for optimizing and 
standardizing dietary management in clinical trials for the development 
of drug products intended to treat IEM when dietary management is a key 
component of patients' metabolic control. Optimizing and standardizing 
dietary management in these patients before they enter into clinical 
trials and during clinical trials is essential to providing an accurate 
evaluation of the efficacy of new drug products.
    This draft guidance revises the draft guidance of the same name 
issued on July 24, 2018 (83 FR 35006). FDA considered comments received 
on the draft guidance and is reissuing the guidance in draft form. 
Revisions from the previous draft include: (1) clarification that drug 
products, including both small molecules and biological products, 
should be studied in conjunction with dietary management for conditions 
where dietary management is the current standard of clinical care; (2) 
clarification that metabolic control may be evaluated by biochemical 
analytes and clinical assessment as substantiated by current clinical 
standards of care; (3) clarification that differences in baseline 
dietary management standards among patients from different countries 
should be considered and clearly stated in the protocol; and (4) 
clarification that the

[[Page 44365]]

most informative design is a randomized, double-blind clinical trial 
that includes a concurrent control group (approved drug or placebo).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Inborn 
Errors of Metabolism That Use Dietary Management: Considerations for 
Optimizing and Standardizing Diet in Clinical Trials for Drug Product 
Development.'' 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 the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 have been approved under OMB Control 
No. 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14691 Filed 7-11-23; 8:45 am]
BILLING CODE 4164-01-P
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