2023-12258. Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) 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 solicits comments on the information collection provisions related to FDA's regulation on importation of prescription drugs.

DATES:

Either electronic or written comments on the collection of information must be submitted by August 7, 2023.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 7, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received 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 the Docket No. FDA–2023–N–1189 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs.” 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:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 240–994–7399, [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.

Importation of Prescription Drugs—21 CFR Part 251

OMB Control Number 0910–0888—Extension

This information collection supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384), and applicable regulations in part 251 (21 CFR part 251). The purpose of section 804 of the FD&C Act is to reduce the cost of covered products to American consumers without imposing additional risk to public health and safety. The regulations in part 251 set forth procedures Section 804 Importation Program sponsors (SIP Sponsors) must follow when submitting plans to implement time-limited programs to begin importation of drugs from Canada. The regulations also establish criteria for FDA review and authorization of a SIP proposal or supplemental proposal. Additionally, the regulations set forth requirements for eligible prescription drugs and requirements for entities that engage in importation of eligible prescription drugs. Finally, the regulations provide for exempt eligible prescription drugs that meet certain requirements from section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).

Description of Respondents: Respondents to the collection of information are SIP Sponsors (States or Indian Tribes, or in certain future circumstances, pharmacists or wholesale distributors, and any cosponsor(s)), importers (pharmacists or wholesaler distributors), and manufacturers of eligible prescription drugs.

We estimate the burden of the collection of information as follows:

Table 1—Estimated Annual Recordkeeping Burden ¹

21 CFR section 251; information collection activity	Number of respondents	Number of records per recordkeeper	Total annual records	Average burden per record	Total hours
Subpart B; SIP proposals and pre-import requests	40	1.5	60	72	4,320
Subpart C; Certain requirements for importation programs	40	1	40	43	1,720
Total			100		6,040
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

We have established a web page at https://www.fda.gov/​about-fda/​reports/​importation-drugs-originally-intended-foreign-markets to communicate news and information about FDA efforts to implement the Section 804 Importation Program. To date, however, no SIP proposals have been authorized since publication of the final rule on October 1, 2020 (85 FR 62094). We have therefore retained figures based on our original impact analysis estimating that 40 SIP sponsors will each submit a SIP proposal or pre-import request. We assume burden attributable to the required retention and disclosure of records pertaining to these information collection activities will be distributed among respondents for an average of 100 responses and 6,040 hours annually.

Dated: June 5, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.