[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42485-42487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15161]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1615]


Instructions for Use--Patient Labeling for Human Prescription 
Drug and Biological Products--Content and Format; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled 
``Instructions for Use--Patient Labeling for Human Prescription Drug 
and Biological Products--Content and Format.'' This guidance provides 
recommendations for developing the content and format of an 
Instructions for Use (IFU) document for human prescription drug and 
biological products, as well as drug-led or biologic-led combination 
products submitted under a new drug application (NDA) or a biologics 
license application (BLA). The IFU is written for patients (or their 
caregivers) who use drug products that have complicated or detailed 
patient-use instructions. The recommendations in this guidance are 
intended to help ensure that patients receive clear and concise 
information that is easily understood for the safe and

[[Page 42486]]

effective use of such products. This guidance finalizes the draft 
guidance issued on July 2, 2019, entitled ``Instructions for Use--
Patient Labeling for Human Prescription Drug and Biological Products 
and Drug-Device and Biologic-Device Combination Products--Content and 
Format.''

DATES: The announcement of the guidance is published in the Federal 
Register on July 15, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2019-D-1615 for ``Instructions for Use--Patient Labeling for Human 
Prescription Drug and Biological Products.'' 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.
    <bullet> 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 this 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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Wheeler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796-
0151; 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, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Instructions for Use--Patient Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' The 
recommendations in this guidance are intended to help ensure that 
patients receive clear and concise information that is easily 
understood for the safe and effective use of such products and to help 
provide consistency to the content and format of IFU documents.
    The IFU is a form of prescription drug labeling. For drugs for 
which self-administration may be complicated (such as requiring the 
patient to perform multiple steps to prepare, administer, store, and/or 
dispose of the drug), the IFU is intended to give directions that are 
clear and understandable for patients, and therefore, promote the safe 
and effective use of that drug. For example, IFUs may be appropriate 
for a drug product with one set of dosing instructions for adult 
patients and another set for pediatric patients. The IFU is developed 
by the applicant, reviewed and approved by FDA, and provided to 
patients when the drug product is dispensed.
    This guidance finalizes the draft guidance entitled ``Instructions 
for Use--Patient Labeling for Human Prescription Drug and Biological 
Products and Drug-Device and Biologic-Device Combination Products--
Content and Format,'' issued on July 2, 2019 (84 FR 31598). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include a 
change in title in addition to editorial changes to improve clarity.
    This guidance is being issued consistent with FDA's good guidance

[[Page 42487]]

practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Instructions for Use--Patient Labeling for 
Human Prescription Drug and Biological Products--Content and Format.'' 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 201 have been approved under OMB control 
number 0910-0572; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

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

    Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15161 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P