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for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability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)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for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 This draft guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles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.

[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Methods for Product Quality Assessments; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Use of 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 This draft guidance applies to orally administered drug 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DATES: Submit either electronic or written comments on the draft 
guidance by September 24, 2018 to ensure that the Agency considers your 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