Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability, 33368-33370 [2024-09156]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 33368 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices information on the cover sheet and not in the body of your comments and you must identify the 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: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–2855, email: EMDAC@fda.hhs.gov, or FDA Advisory Committee Information 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 FDA’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 the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee will discuss the safety and efficacy of biologics license application 761326 for NNC0148–0287 injection (insulin icodec), a long-acting insulin analog product, submitted by Novo Nordisk. The proposed indication is to improve glycemic control in adults with diabetes mellitus. 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 VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https:// www.fda.gov/AdvisoryCommittees/ Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions to the Docket (see ADDRESSES) on or before May 16, 2024, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time. 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 May 10, 2024. Time allotted for each presentation may be 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 May 13, 2024. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. 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 LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) 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/Advisory Committees/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. 1001 et seq.). This meeting notice PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: April 24, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09158 Filed 4–26–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–D–1461] Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.’’ This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly. DATES: Submit either electronic or written comments on the draft guidance by June 28, 2024 to ensure that the Agency considers your comment on this SUMMARY: E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 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: khammond on DSKJM1Z7X2PROD with NOTICES 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– 2024–D–1461 for ‘‘Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.’’ 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 VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 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. 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: Rachel Erdman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1715, 301–348–3984, Rachel.Erdman@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 33369 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.’’ Section 505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(1)(A)) requires, among other things, that an NDA includes ‘‘a full list of the articles used as components of such drug’’ and ‘‘a full statement of the composition of such drug.’’ Further, the regulations at § 314.50(d)(1)(ii)(a) (21 CFR 314.50(d)(1)(ii)(a)) require NDA holders to provide a ‘‘list of all components used in the manufacture of the drug product (regardless of whether they appear in the drug product) and a statement of the composition of the drug product . . .’’ An ANDA applicant is also required to list all components used in the manufacture of the drug product and a statement of the composition of the drug product (§ 314.50(d)(1)(ii)(a)) and must also identify and characterize the inactive ingredients (21 CFR 314.94(a)(9)(ii)). This guidance is intended to assist NDA and ANDA applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in labeling when applicable (21 CFR 201.100 requires labeling for certain drug products to include information on inactive ingredients). This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are clear. This guidance includes examples of common, recurring problems identified during FDA’s preliminary and substantive assessment of NDAs and ANDAs with respect to the content and format of the composition statement in NDAs and ANDAs and the corresponding statement of ingredients in labeling. 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 ‘‘Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an E:\FR\FM\29APN1.SGM 29APN1 33370 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 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. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 314 relating to the submission of NDAs and ANDAs, as well as related postapproval submissions (including annual reports) and drug master files have been approved under OMB control number 0910–0001. The collections of information in 21 CFR 201.56 and 201.57 pertaining to the content and format requirements of labeling for prescription drug products have been approved under OMB control number 0910–0572. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: April 24, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09156 Filed 4–26–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–P–5450] Determination That FLUDARABINE PHOSPHATE Injection, 50 Milligrams/2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) has determined that FLUDARABINE PHOSPHATE Injection, 50 milligrams (mg)/2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993–0002, 301– 796–1546, Kaetochi.Okemgbo@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, is the subject of NDA 022137, held by Sandoz Inc., and initially approved on September 21, 2007. FLUDARABINE PHOSPHATE Injection is indicated for the treatment of adult patients with B-cell chronic PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 lymphocytic leukemia who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The drug product is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Hisun Pharmaceutical (Hangzhou) Co., Ltd. submitted a citizen petition dated December 12, 2023 (Docket No. FDA–2023–P–5450), under 21 CFR 10.30, requesting that the Agency determine whether FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. Dated: April 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–09050 Filed 4–26–24; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33368-33370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-1461]


Content and Format of Composition Statement and Corresponding 
Statement of Ingredients in Labeling in New Drug Applications and 
Abbreviated New Drug Applications; 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 ``Content 
and Format of Composition Statements in NDAs and ANDAs and 
Corresponding Statement of Ingredients in Labeling.'' This guidance is 
intended to assist new drug application (NDA) and abbreviated new drug 
application (ANDA) applicants in submitting an accurate and complete 
composition statement in their applications and corresponding statement 
of ingredients in the labeling, when applicable. This guidance 
describes best practices for writing the composition statement and 
corresponding statement of ingredients in labeling. This guidance 
recommends how applicants can provide complete information with the 
goal of minimizing the number of assessment cycles and communications 
that are necessary for approval, as well as ensuring product labels are 
written clearly.

DATES: Submit either electronic or written comments on the draft 
guidance by June 28, 2024 to ensure that the Agency considers your 
comment on this

[[Page 33369]]

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-2024-D-1461 for ``Content and Format of Composition Statements in 
NDAs and ANDAs and Corresponding Statement of Ingredients in 
Labeling.'' 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. 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: Rachel Erdman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1715, 301-348-3984, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Content and Format of Composition Statements in NDAs and 
ANDAs and Corresponding Statement of Ingredients in Labeling.'' Section 
505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 355(b)(1)(A)) requires, among other things, that an NDA includes 
``a full list of the articles used as components of such drug'' and ``a 
full statement of the composition of such drug.'' Further, the 
regulations at Sec.  314.50(d)(1)(ii)(a) (21 CFR 314.50(d)(1)(ii)(a)) 
require NDA holders to provide a ``list of all components used in the 
manufacture of the drug product (regardless of whether they appear in 
the drug product) and a statement of the composition of the drug 
product . . .'' An ANDA applicant is also required to list all 
components used in the manufacture of the drug product and a statement 
of the composition of the drug product (Sec.  314.50(d)(1)(ii)(a)) and 
must also identify and characterize the inactive ingredients (21 CFR 
314.94(a)(9)(ii)).
    This guidance is intended to assist NDA and ANDA applicants in 
submitting an accurate and complete composition statement in their 
applications and corresponding statement of ingredients in labeling 
when applicable (21 CFR 201.100 requires labeling for certain drug 
products to include information on inactive ingredients). This guidance 
describes best practices for writing the composition statement and 
corresponding statement of ingredients in labeling. This guidance 
recommends how applicants can provide complete information with the 
goal of minimizing the number of assessment cycles and communications 
that are necessary for approval, as well as ensuring product labels are 
clear. This guidance includes examples of common, recurring problems 
identified during FDA's preliminary and substantive assessment of NDAs 
and ANDAs with respect to the content and format of the composition 
statement in NDAs and ANDAs and the corresponding statement of 
ingredients in labeling.
    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 ``Content and 
Format of Composition Statements in NDAs and ANDAs and Corresponding 
Statement of Ingredients in Labeling.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an

[[Page 33370]]

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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 314 relating to the submission of NDAs and ANDAs, as 
well as related postapproval submissions (including annual reports) and 
drug master files have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR 201.56 and 201.57 
pertaining to the content and format requirements of labeling for 
prescription drug products have been approved under OMB control number 
0910-0572.

III. Electronic Access

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

    Dated: April 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09156 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P

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