2022-13536. Agency Information Collection Activities; Proposed Collection; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice requests comments on information collection associated with the communication of important safety information to medical practitioners.

DATES:

Submit either electronic or written comments on the collection of information by August 23, 2022.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 23, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 23, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

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 Docket No. FDA-2010-D-0319 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information.” Received comments, those filed in a timely manner (see ADDRESSES ), 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.

• 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.

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, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Improving Communication of Important Safety Information—21 CFR Part 200

OMB Control Number 0910-0754—Extension

This information collection supports Agency regulations and recommendations found in associated Agency guidance, as discussed below. Under section 705 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health and Human Services (the Secretary) may require dissemination of information for drugs in situations that involve, in the Secretary's opinion, “imminent danger to health, or gross deception of the consumer.” Implementing regulations are found in § 200.5 (21 CFR 200.5) and outline the general provisions for “Dear Healthcare Provider” (DHCP) letters that manufacturers and distributors disseminate about important drug warnings, important prescribing information, and important correction of drug information. The regulations also prescribe certain format and content instructions regarding the dissemination of covered information. Manufacturers or distributors send DHCP letters to physicians and other healthcare providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. We developed the guidance document entitled “Dear Healthcare Provider Letters: Improving Communication of Important Safety Information” (January 2014), available at https://www.fda.gov/​media/​79793/​download, to provide instructions and recommendations to respondents on implementing the applicable requirements. All Agency guidance documents are issued consistent with our good guidance practice regulations at 21 CFR 10.115.

In addition to the content and format recommendations for each type of DHCP letter, the guidance also includes recommendations on consulting with FDA on: (1) how to develop a DHCP letter; (2) when to send a letter; (3) what type of letter to send; and (4) how to assess the letter's impact.

We estimate the burden of the information collection as follows:

Table 1—Estimated Annual Reporting Burden ¹

Activity; 21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average time per response (in hours)	Total hours
Preparation of DHCP letters; § 200.5	6	1.3	8	100	800
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We have identified 24 DHCP letters that 18 distinct sponsors submitted to FDA during the 3-year period (2019 to 2021). Based on our Document Archiving, Reporting, and Regulatory Tracking System, we estimate eight DHCP letters will be submitted annually from six application holders. Based on our experience, we assume that each letter will require 100 hours to prepare and disseminate as recommended in the guidance. Our estimate reflects a downward adjustment by five responses and 500 hours annually. We attribute this decrease to the effectiveness of the guidance and the decreased number of DHCP letters submitted for FDA review.

Dated: June 16, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.