Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by December 21, 2018.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0572. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products

OMB Control Number 0910-0572—Extension

FDA's regulations governing the content and format of labeling for human prescription drug and biological products were revised in the Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling rule) to require that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements. These revisions were intended to make it easier for health care practitioners to access, read, and use information in prescription drug labeling; to enhance the safe and effective use of prescription drug products; and to reduce the number of adverse reactions resulting from medication errors because of misunderstood or incorrectly applied drug information.

Currently, § 201.56 (21 CFR 201.56) requires that prescription drug labeling contain certain information in the format specified in either § 201.57 (21 CFR 201.57) or § 201.80 (21 CFR 201.80), depending on when the drug was approved for marketing. Section 201.56(a) sets forth general labeling requirements applicable to all prescription drugs. Section 201.56(b) specifies the categories of new and more recently approved prescription drugs subject to the revised content and format requirements in §§ 201.56(d) and 201.57. Section 201.56(c) sets forth the schedule for implementing these revised content and format requirements. Section 201.56(e) specifies the sections and subsections, required and optional, for the labeling of older prescription drugs not subject to the revised format and content requirements.

Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include a “Highlights of Prescribing Information” section. The “Highlights” section provides a concise extract of the most important information required under § 201.57(c) (the Full Prescribing Information (FPI)), as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to prescribing information entitled “Full Prescribing Information: Contents,” consisting of a list of each heading and subheading along with its identifying number to facilitate health care practitioners' use of labeling information. Section 201.57(c) specifies the contents of the FPI. Section 201.57(d) mandates the minimum specifications for the format of prescription drug labeling and establishes minimum requirements for key graphic elements such as bold type, bullet points, type size, and spacing.

Older drugs not subject to the revised labeling content and format requirements in § 201.57 are subject to labeling requirements at § 201.80. Section 201.80(f)(2) requires that, within 1 year, any FDA-approved patient labeling be referenced in the “Precautions” section of the labeling of older products and either accompany or be reprinted immediately following the labeling.

Annual Burden for Prescription Drug Labeling Design, Testing, and Submitting to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs) (§§ 201.56 and 201.57)

New drug product applicants must: (1) Design and create prescription drug labeling containing “Highlights,” “Contents,” and FPI; (2) test the designed labeling (e.g., to ensure that the designed labeling fits into carton-enclosed products); and (3) submit it to FDA for approval. Based on the projected data used in the January 24, 2006, final rule, FDA estimates that it will take applicants approximately 2,327 hours to design, test, and submit prescription drug labeling to FDA as part of a NDA or a BLA under the revised regulations. Currently, approximately 406 applicants submit approximately 541 new applications (NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.

In the Federal Register of July 20, 2018 (83 FR 34596), we published a 60-day notice requesting public comment on the proposed collection of information. We received two comments. One comment encouraged the use of “provider-neutral language” in specific regulations. The second comment discussed the distribution of package inserts for prescription drugs via paper labeling. Because these comments do not apply to the regulations associated with the information collection, we have not addressed them here.

Our estimate of the burden for the information collection is as follows:

Our estimated burden for the information collection reflects an overall increase of 602,503 hours and a corresponding increase of 345 records. We attribute this adjustment to an increase in the number of submissions we received over the last few years.