83 FR 35006 - 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Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 142 (July 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 142 (July 24, 2018)
| Page Range | 35006-35007 | |
| FR Document | 2018-15777 |
[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)] [Notices] [Pages 35006-35007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15777] ----------------------------------------------------------------------- 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Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for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 This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating inborn errors of metabolism (IEM) for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products. DATES: Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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; Draft Guidance for Industry; Availability.'' 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. 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.thefederalregister.org/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 [[Page 35007]] 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. 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 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: Dina Zand, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5239, Silver Spring, MD 20993, 240-402-2538; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a 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 regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating IEM for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products. 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 how sponsors can optimize and standardize dietary management for clinical trials in the development of drugs for inborn errors of metabolism that use dietary management. 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: July 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15777 Filed 7-23-18; 8:45 am] BILLING CODE 4164-01-P
![35006 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices
otic-vestibular-toxicity-tickets- ACTION: Notice of availability. • Mail/Hand Delivery/Courier (for
47223962142. Please provide complete written/paper submissions): Dockets
contact information for each attendee, SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
including name, title, affiliation, Administration (FDA or Agency) is Drug Administration, 5630 Fishers
address, email, and telephone. announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852.
Registration is free and based on guidance for industry entitled ‘‘Inborn • For written/paper comments
space availability, with priority given to Errors of Metabolism That Use Dietary submitted to the Dockets Management
early registrants. Persons interested in Management: Considerations for Staff, FDA will post your comment, as
attending this public workshop must Optimizing and Standardizing Diet in well as any attachments, except for
register by August 20, 2018, midnight Clinical Trials for Drug Product information submitted, marked and
Eastern Time. Early registration is Development.’’ This draft guidance identified, as confidential, if submitted
recommended because seating is describes FDA’s current as detailed in ‘‘Instructions.’’
limited; therefore, FDA may limit the recommendations regarding how to Instructions: All submissions received
number of participants from each optimize and standardize dietary must include the Docket No. FDA–
organization. management in clinical trials for the 2018–D–2647 for ‘‘Inborn Errors of
For any participant in need of sign development of drugs treating inborn Metabolism That Use Dietary
language interpretation, please send an errors of metabolism (IEM) for which Management: Considerations for
email request to Interpreting.Services@ dietary management is a key component Optimizing and Standardizing Diet in
oc.fda.gov. For all other reasonable of patients’ metabolic control. Clinical Trials for Drug Product
accommodations, please contact FDA’s Optimizing dietary management in Development; Draft Guidance for
Office of Equal Employment these patients before entry into and Industry; Availability.’’ Received
Opportunity at 301–796–9400. during the clinical trial(s) is essential to comments will be placed in the docket
Streaming webcast of the public providing an accurate evaluation of the and, except for those submitted as
workshop: This public workshop will efficacy of new drug products. ‘‘Confidential Submissions,’’ publicly
also be webcast at https:// DATES: Submit either electronic or
viewable at https://www.regulations.gov
collaboration.fda.gov/ovtw/. written comments on the draft guidance or at the Dockets Management Staff
If you have never attended a Connect by September 24, 2018 to ensure that between 9 a.m. and 4 p.m., Monday
Pro event before, test your connection at the Agency considers your comment on through Friday.
• Confidential Submissions—To
https://collaboration.fda.gov/common/ this draft guidance before it begins work
submit a comment with confidential
help/en/support/meeting_test.htm. To on the final version of the guidance.
information that you do not wish to be
get a quick overview of the Connect Pro ADDRESSES: You may submit comments made publicly available, submit your
program, visit https://www.adobe.com/ on any guidance at any time as follows: comments only as a written/paper
go/connectpro_overview. FDA has
Electronic Submissions submission. You should submit two
verified the website addresses in this
copies total. One copy will include the
document, as of the date this document Submit electronic comments in the information you claim to be confidential
publishes in the Federal Register, but following way: with a heading or cover note that states
websites are subject to change over time. • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Transcripts: Please be advised that as https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
soon as a transcript of the public instructions for submitting comments. Agency will review this copy, including
workshop is available, it will be Comments submitted electronically, the claimed confidential information, in
accessible at https:// including attachments, to https:// its consideration of comments. The
www.regulations.gov. It may be viewed www.regulations.gov will be posted to second copy, which will have the
at the Dockets Management Staff (HFA– the docket unchanged. Because your claimed confidential information
305), Food and Drug Administration, comment will be made public, you are redacted/blacked out, will be available
5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your for public viewing and posted on
MD 20852. comment does not include any https://www.regulations.gov. Submit
Dated: July 18, 2018. confidential information that you or a both copies to the Dockets Management
Leslie Kux, third party may not wish to be posted, Staff. If you do not wish your name and
Associate Commissioner for Policy. such as medical information, your or contact information to be made publicly
[FR Doc. 2018–15779 Filed 7–23–18; 8:45 am]
anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
BILLING CODE 4164–01–P
as a manufacturing process. Please note in the body of your comments and you
that if you include your name, contact must identify this information as
DEPARTMENT OF HEALTH AND information, or other information that ‘‘confidential.’’ Any information marked
HUMAN SERVICES identifies you in the body of your as ‘‘confidential’’ will not be disclosed
comments, that information will be except in accordance with 21 CFR 10.20
Food and Drug Administration posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
[Docket No. FDA–2018–D–2647]
with confidential information that you of comments to public dockets, see 80
Inborn Errors of Metabolism That Use do not wish to be made available to the FR 56469, September 18, 2015, or access
jstallworth on DSKBBY8HB2PROD with NOTICES
Dietary Management: Considerations public, submit the comment as a the information at: https://www.gpo.gov/
for Optimizing and Standardizing Diet written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
in Clinical Trials for Drug Product manner detailed (see ‘‘Written/Paper 23389.pdf.
Development; Draft Guidance for Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Industry; Availability read background documents or the
Written/Paper Submissions electronic and written/paper comments
AGENCY: Food and Drug Administration, Submit written/paper submissions as received, go to https://
HHS. follows: www.regulations.gov and insert the
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![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35007
docket number, found in brackets in the drugs for inborn errors of metabolism recommendations to the Agency. The
heading of this document, into the that use dietary management. It does not meeting will be open to the public. FDA
‘‘Search’’ box and follow the prompts establish any rights for any person and is establishing a docket for public
and/or go to the Dockets Management is not binding on FDA or the public. comment on this document.
Staff, 5630 Fishers Lane, Rm. 1061, You can use an alternative approach if DATES: The meeting will be held on
Rockville, MD 20852. it satisfies the requirements of the September 12, 2018, from 8 a.m. to 4:30
You may submit comments on any applicable statutes and regulations. This p.m.
guidance at any time (see 21 CFR guidance is not subject to Executive ADDRESSES: FDA White Oak Campus,
10.115(g)(5)). Order 12866. 10903 New Hampshire Ave., Bldg. 31
Submit written requests for single II. Paperwork Reduction Act of 1995 Conference Center, the Great Room (Rm.
copies of the draft guidance to the 1503), Silver Spring, MD 20993–0002.
Division of Drug Information, Center for This draft guidance refers to
previously approved collections of Answers to commonly asked questions
Drug Evaluation and Research, Food including information regarding special
and Drug Administration, 10001 New information found in FDA regulations.
These collections of information are accommodations due to a disability,
Hampshire Ave., Hillandale Building, visitor parking, and transportation may
4th Floor, Silver Spring, MD 20993– subject to review by the Office of
Management and Budget (OMB) under be accessed at: https://www.fda.gov/
0002, or Office of Communication, AdvisoryCommittees/
Outreach, and Development, Center for the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections AboutAdvisoryCommittees/
Biologics Evaluation and Research, ucm408555.htm.
Food and Drug Administration, 10903 of information in 21 CFR part 312 have
been approved under OMB control FDA is establishing a docket for
New Hampshire Ave., Bldg. 71, Rm. public comment on this meeting. The
3128, Silver Spring, MD 20993–0002. number 0910–0014.
docket number is FDA–2018–N–2733.
Send one self-addressed adhesive label III. Electronic Access The docket will close on September 11,
to assist that office in processing your 2018. Submit either electronic or
Persons with access to the internet
requests. See the SUPPLEMENTARY written comments on this public
may obtain the draft guidance at either
INFORMATION section for electronic
https://www.fda.gov/Drugs/Guidance meeting by September 11, 2018. Please
access to the draft guidance document. note that late, untimely filed comments
ComplianceRegulatoryInformation/
FOR FURTHER INFORMATION CONTACT: Dina Guidances/default.htm, https:// will not be considered. Electronic
Zand, Center for Drug Evaluation and www.fda.gov/BiologicsBloodVaccines/ comments must be submitted on or
Research, Food and Drug GuidanceComplianceRegulatory before September 11, 2018. The https://
Administration, 10903 New Hampshire Information/Guidances/default.htm, or www.regulations.gov electronic filing
Ave., Bldg. 22, Rm. 5239, Silver Spring, https://www.regulations.gov. system will accept comments until
MD 20993, 240–402–2538; or Stephen midnight Eastern Time at the end of
Ripley, Center for Biologics Evaluation Dated: July 17, 2018.
September 11, 2018. Comments received
and Research, Food and Drug Leslie Kux,
by mail/hand delivery/courier (for
Administration, 10903 New Hampshire Associate Commissioner for Policy. written/paper submissions) will be
Ave., Bldg. 71, Rm. 7301, Silver Spring, [FR Doc. 2018–15777 Filed 7–23–18; 8:45 am] considered timely if they are
MD 20993–002, 240–402–7911. BILLING CODE 4164–01–P postmarked or the delivery service
SUPPLEMENTARY INFORMATION: acceptance receipt is on or before that
date.
I. Background DEPARTMENT OF HEALTH AND Comments received on or before
FDA is announcing the availability of HUMAN SERVICES August 28, 2018, will be provided to the
a draft guidance for industry entitled committee. Comments received after
Food and Drug Administration
‘‘Inborn Errors of Metabolism That Use that date will be taken into
Dietary Management: Considerations for [Docket No. FDA–2018–N–2733] consideration by FDA.
Optimizing and Standardizing Diet in You may submit comments as
Clinical Trials for Drug Product Pharmacy Compounding Advisory follows:
Development.’’ This draft guidance Committee; Notice of Meeting;
describes FDA’s current Establishment of a Public Docket; Electronic Submissions
recommendations regarding how to Request for Comments Submit electronic comments in the
optimize and standardize dietary AGENCY: Food and Drug Administration, following way:
management in clinical trials for the HHS. • Federal eRulemaking Portal:
development of drugs treating IEM for ACTION: Notice; establishment of a https://www.regulations.gov. Follow the
which dietary management is a key public docket; request for comments. instructions for submitting comments.
component of patients’ metabolic Comments submitted electronically,
control. Optimizing dietary management SUMMARY: The Food and Drug including attachments, to https://
in these patients before entry into and Administration (FDA) announces a www.regulations.gov will be posted to
during the clinical trial(s) is essential to forthcoming public advisory committee the docket unchanged. Because your
providing an accurate evaluation of the meeting of the Pharmacy Compounding comment will be made public, you are
efficacy of new drug products. Advisory Committee (PCAC). The solely responsible for ensuring that your
This draft guidance is being issued general function of the committee is to comment does not include any
jstallworth on DSKBBY8HB2PROD with NOTICES
consistent with FDA’s good guidance provide advice on scientific, technical, confidential information that you or a
practices regulation (21 CFR 10.115). and medical issues concerning drug third party may not wish to be posted,
The draft guidance, when finalized, will compounding under the Federal Food, such as medical information, your or
represent the current thinking of FDA Drug, and Cosmetic Act (FD&C Act), anyone else’s Social Security number, or
on how sponsors can optimize and and, as required, any other product for confidential business information, such
standardize dietary management for which FDA has regulatory as a manufacturing process. Please note
clinical trials in the development of responsibility, and to make appropriate that if you include your name, contact
VerDate Sep<11>2014 13:59 Jul 23, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1](https://thefederalregister.org/doc/83_FR_35148/page/2.svg)
Document Created: 2018-07-24 00:10:20
Document Modified: 2018-07-24 00:10:20
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Dina Zand, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5239, Silver Spring, MD 20993, 240-402-2538; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-002, 240-402-7911. | |
| FR Citation | 83 FR 35006 |
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