83 FR 35277 - Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 143 (July 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 143 (July 25, 2018)
| Page Range | 35277-35278 | |
| FR Document | 2018-15870 |
[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)] [Notices] [Pages 35277-35278] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15870] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2544] Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' This draft guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications. DATES: Submit either electronic or written comments on the draft guidance by September 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-N-2544 for ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' 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. [[Page 35278]] 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 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. 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: Mamta Gautam-Basak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 21, Rm. 2508, Silver Spring, MD 20993, 301-796- 0712. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' In the absence of availability of a dosage form that is appropriate for the targeted patient population (e.g., pediatric, geriatric), small amounts of liquids and/or soft foods can be used as described in the FDA-approved product labeling for immediate ingestion as the suitable vehicle(s) for oral administration of the specific drug product. Generally, drug products mixed in small amounts of liquids (5 to 15 milliliters) or soft foods are used in pediatric and other patient populations who are unable to swallow solid oral dosage forms. Liquids and/or soft foods that are shown not to alter performance of the drug product, and are deemed compatible and suitable for use in the targeted patient populations, are considered suitable for use as vehicles with the specific drug product. This draft guidance addresses the approaches recommended for suitability determination of vehicles intended for use with specific drug products by providing the following: Considerations for selection of liquids and/or soft foods as vehicles. Standardized in vitro methodology and data recommendations for drug product quality assessments to qualify vehicle(s) for drug product administration. Recommendations to communicate acceptable (qualified) vehicles in drug product labeling. If certain foods are found unacceptable, they should also be included in the labeling. This draft guidance and the methods it describes do not replace existing guidance documents that address food-effect assessments on the drug product or dosage form, or stability testing conducted to support a shelf-life determination. For those drug products marketed with a vehicle for administration (i.e., the vehicle is copackaged with the drug product), the recommendations regarding selection and methods provided in this draft guidance are applicable, but additional considerations and recommendations may also apply. 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 ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' 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 that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 (INDs) have been approved under 0910-0014, the collections of information in 21 CFR part 314 (NDAs and ANDAs) have been approved under 0910-0001, and the collections of information in 21 CFR 201.56 and 201.57 (Prescription Drug Product Labeling) have been approved under 0910-0572. 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 or https://www.regulations.gov. Dated: July 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15870 Filed 7-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices 35277
informed decisions about the The information requested by ACL Register on December 5, 2017 (Volume
deployment of its resource center assets. from legal and aging/disability 82, Number 232, pp. 57458–57460). One
These data are necessary for ACL to professionals falls into the following email was received expressing support
evaluate contractual compliance with areas: (1) Requests for training, case for the data collection as proposed. No
established performance indicators. consultation, and technical assistance modifications were made to the
These metrics include quantifiable through an online, secure Uniform proposed data collection elements and
increases in uptake by stakeholders of Resource Support Request Tool; (2) associated data collection instruments.
training, case consultation and technical general requests for Legal Training
(including the volume of Webinar Estimated Annualized Burden Hours
assistance, and measures of satisfaction
with and perceived benefit from these registrations); (3) Case Consultation and
Technical Assistance; and (4) The total estimated burden is 460.78
services. For example, the metrics hours per year for individuals
information about satisfaction and use
measure successful problem resolution requesting and/or receiving resource
of the services and support received in
as a result of the services provided and order to enable ACL to measure support through NCLER. This figure is
quantifiable data on fulfillment of performance outcomes. based on ACL field testing of 8
requests for training, technical providers working within aging/
assistance, and consultation related to Comments in Response to the 60-Day disability/legal networks who measured
the contractually designated legal and Federal Register Notice the time required to fully submit
systems development topic areas. As required by 5 CFR 1320.8(d), a 60- information by answering the required
day notice was published in the Federal questions using standardized forms:
Number of Minutes per Annual burden
Respondent/data collection activity respondents response hours
Resource Support Requests .................................................................................................... 80 1 min 54 sec ..... 2.53
Legal Training, Case Consultation, Technical Assistance Requests ....................................... 14,000 1 min 42 sec ..... 397
Outcome Measurement ............................................................................................................ 3,500 1 min 3 sec ....... 61.25
Total ................................................................................................................................... 17,580 4 min 39 sec ..... 460.78
Dated: July 12, 2018. drug applications (INDs), new drug • If you want to submit a comment
Mary Lazare, applications (NDAs), Biologics License with confidential information that you
Principal Deputy Administrator. Applications (BLAs), as applicable, and do not wish to be made available to the
[FR Doc. 2018–15906 Filed 7–24–18; 8:45 am] in supplements to these applications. public, submit the comment as a
BILLING CODE 4154–01–P DATES: Submit either electronic or written/paper submission and in the
written comments on the draft guidance manner detailed (see ‘‘Written/Paper
by September 24, 2018 to ensure that Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND the Agency considers your comment on Written/Paper Submissions
HUMAN SERVICES this draft guidance before it begins work
Submit written/paper submissions as
Food and Drug Administration on the final version of the guidance.
follows:
[Docket No. FDA–2018–N–2544] ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
on any guidance at any time as follows: written/paper submissions): Dockets
Use of Liquids and/or Soft Foods as Electronic Submissions Management Staff (HFA–305), Food and
Vehicles for Drug Administration: Drug Administration, 5630 Fishers
General Considerations for Selection Submit electronic comments in the Lane, Rm. 1061, Rockville, MD 20852.
and In Vitro Methods for Product following way: • For written/paper comments
Quality Assessments; Draft Guidance • Federal eRulemaking Portal: submitted to the Dockets Management
for Industry; Availability https://www.regulations.gov. Follow the Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration, instructions for submitting comments. well as any attachments, except for
HHS. Comments submitted electronically, information submitted, marked and
including attachments, to https:// identified, as confidential, if submitted
ACTION: Notice of availability.
www.regulations.gov will be posted to as detailed in ‘‘Instructions.’’
SUMMARY: The Food and Drug the docket unchanged. Because your Instructions: All submissions received
Administration (FDA or Agency) is comment will be made public, you are must include the Docket No. FDA–
announcing the availability of a draft solely responsible for ensuring that your 2018–N–2544 for ‘‘Use of Liquids and/
guidance for industry entitled ‘‘Use of comment does not include any or Soft Foods as Vehicles for Drug
Liquids and/or Soft Foods as Vehicles confidential information that you or a Administration: General Considerations
for Drug Administration: General third party may not wish to be posted, for Selection and In Vitro Methods for
Considerations for Selection and In such as medical information, your or Product Quality Assessments.’’
Vitro Methods for Product Quality anyone else’s Social Security number, or Received comments will be placed in
daltland on DSKBBV9HB2PROD with NOTICES
Assessments.’’ This draft guidance confidential business information, such the docket and, except for those
applies to orally administered drug as a manufacturing process. Please note submitted as ‘‘Confidential
products and provides that if you include your name, contact Submissions,’’ publicly viewable at
recommendations to sponsors who will information, or other information that https://www.regulations.gov or at the
use or recommend use of liquids and/ identifies you in the body of your Dockets Management Staff between 9
or soft foods as vehicles for drug comments, that information will be a.m. and 4 p.m., Monday through
administration in investigational new posted on https://www.regulations.gov. Friday.
VerDate Sep<11>2014 18:50 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/83_FR_35420/page/1.svg)
![35278 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Notices
• Confidential Submissions—To Silver Spring, MD 20993, 301–796– The draft guidance, when finalized, will
submit a comment with confidential 0712. represent the current thinking of FDA
information that you do not wish to be SUPPLEMENTARY INFORMATION:
on ‘‘Use of Liquids and/or Soft Foods as
made publicly available, submit your Vehicles for Drug Administration:
comments only as a written/paper I. Background General Considerations for Selection
submission. You should submit two FDA is announcing the availability of and In Vitro Methods for Product
copies total. One copy will include the a draft guidance for industry entitled Quality Assessments.’’ It does not
information you claim to be confidential ‘‘Use of Liquids and/or Soft Foods as establish any rights for any person and
with a heading or cover note that states Vehicles for Drug Administration: is not binding on FDA or the public.
‘‘THIS DOCUMENT CONTAINS General Considerations for Selection You can use an alternative approach if
CONFIDENTIAL INFORMATION.’’ The and In Vitro Methods for Product it satisfies the requirements of the
Agency will review this copy, including Quality Assessments.’’ In the absence of applicable statutes and regulations. This
the claimed confidential information, in availability of a dosage form that is guidance is not subject to Executive
its consideration of comments. The appropriate for the targeted patient Order 12866.
second copy, which will have the population (e.g., pediatric, geriatric), II. Paperwork Reduction Act of 1995
claimed confidential information small amounts of liquids and/or soft
redacted/blacked out, will be available foods can be used as described in the This draft guidance refers to
for public viewing and posted on FDA-approved product labeling for previously approved collections of
https://www.regulations.gov. Submit immediate ingestion as the suitable information that are subject to review by
both copies to the Dockets Management vehicle(s) for oral administration of the the Office of Management and Budget
Staff. If you do not wish your name and specific drug product. under the Paperwork Reduction Act of
contact information to be made publicly Generally, drug products mixed in 1995 (44 U.S.C. 3501–3520). The
available, you can provide this small amounts of liquids (5 to 15 collections of information in 21 CFR
information on the cover sheet and not milliliters) or soft foods are used in part 312 (INDs) have been approved
in the body of your comments and you pediatric and other patient populations under 0910–0014, the collections of
must identify this information as who are unable to swallow solid oral information in 21 CFR part 314 (NDAs
‘‘confidential.’’ Any information marked dosage forms. Liquids and/or soft foods and ANDAs) have been approved under
as ‘‘confidential’’ will not be disclosed that are shown not to alter performance 0910–0001, and the collections of
except in accordance with 21 CFR 10.20 of the drug product, and are deemed information in 21 CFR 201.56 and
and other applicable disclosure law. For compatible and suitable for use in the 201.57 (Prescription Drug Product
more information about FDA’s posting targeted patient populations, are Labeling) have been approved under
of comments to public dockets, see 80 considered suitable for use as vehicles 0910–0572.
FR 56469, September 18, 2015, or access with the specific drug product.
the information at: https://www.gpo.gov/ III. Electronic Access
This draft guidance addresses the
fdsys/pkg/FR-2015-09-18/pdf/2015- approaches recommended for suitability Persons with access to the internet
23389.pdf. determination of vehicles intended for may obtain the draft guidance at either
Docket: For access to the docket to use with specific drug products by https://www.fda.gov/Drugs/Guidance
read background documents or the providing the following: ComplianceRegulatoryInformation/
electronic and written/paper comments • Considerations for selection of Guidances/default.htm or https://
received, go to https:// liquids and/or soft foods as vehicles. www.regulations.gov.
www.regulations.gov and insert the • Standardized in vitro methodology Dated: July 19, 2018.
docket number, found in brackets in the and data recommendations for drug Leslie Kux,
heading of this document, into the product quality assessments to qualify
Associate Commissioner for Policy.
‘‘Search’’ box and follow the prompts vehicle(s) for drug product
[FR Doc. 2018–15870 Filed 7–24–18; 8:45 am]
and/or go to the Dockets Management administration.
Staff, 5630 Fishers Lane, Rm. 1061, • Recommendations to communicate BILLING CODE 4164–01–P
Rockville, MD 20852. acceptable (qualified) vehicles in drug
You may submit comments on any product labeling. If certain foods are
DEPARTMENT OF HEALTH AND
guidance at any time (see 21 CFR found unacceptable, they should also be
HUMAN SERVICES
10.115(g)(5)). included in the labeling.
This draft guidance and the methods Scholarly and Journalistic Activities
Submit written requests for single
it describes do not replace existing Deemed Not To Be Research: 2018
copies of the draft guidance to the
guidance documents that address food- Requirements; Draft Guidance; When
Division of Drug Information, Center for
effect assessments on the drug product Continuing Review Is Not Required
Drug Evaluation and Research, Food
or dosage form, or stability testing During the 6-Month Delay Period of
and Drug Administration, 10001 New
conducted to support a shelf-life July 19, 2018 Through January 20,
Hampshire Ave., Hillandale Building,
determination. For those drug products 2019: 2018 Requirements; Draft
4th Floor, Silver Spring, MD 20993–
marketed with a vehicle for Guidance Elimination of Institutional
0002. Send one self-addressed adhesive
administration (i.e., the vehicle is Review Board (IRB) Review of
label to assist that office in processing
copackaged with the drug product), the Research Applications and Proposals:
your requests. See the SUPPLEMENTARY
recommendations regarding selection 2018 Requirements; Draft Guidance
daltland on DSKBBV9HB2PROD with NOTICES
INFORMATION section for electronic
and methods provided in this draft
access to the draft guidance document.
guidance are applicable, but additional AGENCY: The Office for Human Research
FOR FURTHER INFORMATION CONTACT: considerations and recommendations Protections, Office of the Assistant
Mamta Gautam-Basak, Center for Drug may also apply. Secretary for Health, Office of the
Evaluation and Research, Food and This draft guidance is being issued Secretary, HHS.
Drug Administration, 10903 New consistent with FDA’s good guidance
ACTION: Notice of availability.
Hampshire Ave. Bldg. 21, Rm. 2508, practices regulation (21 CFR 10.115).
VerDate Sep<11>2014 18:50 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/83_FR_35420/page/2.svg)
Document Created: 2018-07-25 00:45:01
Document Modified: 2018-07-25 00:45:01
| 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 | Mamta Gautam-Basak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 21, Rm. 2508, Silver Spring, MD 20993, 301-796- 0712. | |
| FR Citation | 83 FR 35277 |
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