90 FR 143 pgs. 35697-35698 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
Type: NOTICEVolume: 90Number: 143Pages: 35697 - 35698
Pages: 35697, 35698Docket number: [Docket No. FDA-2025-N-0338]
FR document: [FR Doc. 2025-14229 Filed 7-28-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0338]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
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:
Submit written comments (including recommendations) on the collection of information by August 28, 2025.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0482. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 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.
Export Notification and Recordkeeping Requirements-21 CFR 1.101
OMB Control Number 0910-0482-Extension
This information collection supports FDA regulations. Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381 and 21 U.S.C. 382) charge the Secretary of Health and Human Services, through FDA, with the responsibility of helping to ensure that exports of unapproved new drugs, biologics, devices, animal drugs, food, cosmetics, and tobacco products that are not to be sold in the United States meet the requirements of the country to which the product is to be exported. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered for sale in domestic commerce in the United States as allowed under section 801(e) of the FD&C Act. In general, the notification identifies the product being exported ( e.g., name, description, and in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export. Subsequent exports of the same product to the same destination or to certain countries identified in section 802(b) of the FD&C Act would not result in a notification to FDA.
[top] Respondents to the information collection are exporters of products that may not be sold in the United States and are regulated by FDA's Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM); and Center for Tobacco Products (CTP). Respondents to this collection of information maintain records
In the Federal Register of May 1, 2025 (90 FR 18691), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
| 21 CFR section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Notification requirements for exports; 1.101(d) | |||||
| CBER | 5 | 92 | 460 | 15 | 6,900 |
| CDER | 5 | 2.4 | 12 | 15 | 180 |
| CDRH | 16 | 3.375 | 54 | 15 | 810 |
| Total | 7,890 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| Recordkeeping requirements for exports; 101(b), (c), and (e) | |||||
| CBER | 17 | 3 | 51 | 22 | 1,122 |
| CDER | 121 | 7.9 | 956 | 22 | 21,032 |
| CDRH | 16 | 3 | 48 | 22 | 1,056 |
| CVM | 26 | 3 | 78 | 22 | 1,716 |
| Recordkeeping requirements for exports; 1.101(b) | |||||
| Office of Global Policy and Strategy | 1 | 65 | 65 | 22 | 1,430 |
| CTP | 322 | 3 | 966 | 22 | 21,252 |
| Total | 47,608 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
In table 1, we estimate the number of respondents increased for biologics from 4 to 5. The number of respondents increased for drugs from 3 to 5. However, this increase is offset by respondents for devices as the estimated number of exporters decreased from 22 to 16. The number of responses per respondent increased for biologics from 35 to 92 resulting in an increase in burden for biologics reporting from 2,100 to 6,900. Despite decreases in the number of responses per respondent for drugs and devices, the increase in biologics reporting resulted in an overall total reporting burden increase from 5,985 to 7,890.
In table 2, we separated each center's recordkeeping to ensure consistency with table 1 and to accurately capture each center's burden estimates. The average No. of Records Per Recordkeeper increased from 4.12 to 14.15 which represents a total recordkeeping burden increase from 39,094 to 47,608.
Based on a review of Agency data, our estimated burden for the information collection reflects an overall increase of 10,419 hours and a corresponding increase of 514 responses. In the previous extension request FDA included burden for the Center for Food Safety and Applied Nutrition (now known as Human Foods Program (HFP)). However, upon reevaluation of these burden estimates, we have determined that the burden associated with HFP is already accounted for under OMB Control Number 0910-0793.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14229 Filed 7-28-25; 8:45 am]
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