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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription ( printed page 58422) drugs. This guidance finalizes the revised draft guidance issued on November 20, 2013 (“Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling”).
FDA is also 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 (the PRA).
The announcement of the guidance is published in the Federal Register on December 12, 2017.
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—New and title “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” Also, include the FDA docket number found in brackets in the heading of this document.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-1999-D-4079 for “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability.” 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.
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 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 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; or the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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.
Regarding human prescription drugs: Sheila Ryan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3320, Silver Spring, MD 20993-0002, 301-796-1200. Regarding human prescription biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding animal prescription drugs: Thomas Moskal, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6251.
FDA is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product ( printed page 58423) name in promotional labeling and advertisements for all human prescription drugs, including prescription biological products, and animal prescription drugs is important for the proper identification of such products to ensure their safe and effective use.
The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and for prescription animal drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h) and 202.1(b), (c), and (d)).
The recommendations in this guidance pertain to product names in traditional print promotional labeling and advertisements ( e.g., journal ads, detail aids, brochures), audiovisual promotional labeling ( e.g., videos shown in a health care provider's office), broadcast advertisements ( e.g., television advertisements, radio advertisements), and electronic and computer-based promotions ( e.g., internet, social media, emails, CD-ROMs, DVDs).
In the Federal Register of November 20, 2013 (78 FR 69691), FDA announced the availability of the revised draft guidance entitled “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.” FDA received one comment on the revised draft guidance, which requested additional clarification on the individual recommendations in the guidance, and FDA considered this comment as the guidance was finalized. In addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised draft guidance and to provide examples illustrating prominence issues.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” 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.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. The information collection requests in support of the guidance are discussed below. Specifically, the guidance discusses the requirement in FDA's regulations for prescription drug promotional labeling and advertisements to include the established name in conjunction with the proprietary name, and explains FDA recommendations that:
Thus, the guidance recommends that firms disclose certain information to others to fulfill the product name placement requirements found in FDA's regulations. This “third-party disclosure” constitutes a “collection of information” under the PRA. Disclosures in advertising pursuant to 21 CFR 202.1 are covered by an existing information collection (OMB control number 0910-0686), so this information collection request covers only disclosures in labeling in accordance with 21 CFR 201.10(g) and (h).
In the Federal Register of November 20, 2013, FDA published a 60-day notice requesting public comment on the proposed collection of information and the estimated annual burden for third party disclosure. FDA received no comments in response to the four information collection topics solicited in the notice. FDA has received more up-to-date submission data since the 60-day notice published, therefore, we have adjusted our estimates of respondents and disclosures accordingly. The estimated amount of time per disclosure has not changed. We therefore estimate the burden associated with the information collection as follows:
| Guidance recommendations | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure (in hours) | Total hours |
|---|---|---|---|---|---|
| Disclosures Related to Product Name Placement, Size, and Prominence | 407 | 256.4 | 104,358 | 3 | 313,074 |
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
As reflected in table 1, we provide an estimate of the annual third-party disclosure burden associated with this collection of information. The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and animal prescription drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h); 202.1(b), (c) and (d); and 610.62). Using calendar year 2015 data, FDA estimates that, for prescription human and animal drugs and biological products, approximately 407 firms disseminate approximately 104,358 advertisements and promotional pieces each year. We further estimate that the burden hours associated with the regulatory requirements would be approximately 3 hours per disclosure.
FDA is issuing this final guidance subject to OMB approval of the information collection. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the Federal Register announcing OMB's decision to ( printed page 58424) approve, modify, or disapprove the collections of information, including OMB control number(s) for newly approved collections.
This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information associated with 21 CFR 202.1 have been approved under OMB control number 0910-0686.
Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26725 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P