89 FR 245 pgs. 104188-104191 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
Type: NOTICEVolume: 89Number: 245Pages: 104188 - 104191
Pages: 104188, 104189, 104190, 104191Docket number: [Docket No. FDA-2024-N-3902]
FR document: [FR Doc. 2024-30355 Filed 12-19-24; 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-2024-N-3902]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
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 January 21, 2025.
ADDRESSES:
[top] 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 0910-0045. Also include the FDA docket number found in
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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.
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
OMB Control Number 0910-0045-Revision
This information collection supports implementation of requirements related to drug establishment registration and listing governed by section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), including registrant reporting under section 510(j)(3) of the FD&C Act with respect to listed drugs. The information collection also supports implementation of section 510(j)(3)(B) of the FD&C Act, which authorizes the Secretary of Health and Human Services (the Secretary), by order, to exempt from some or all of the section 510(j)(3) reporting requirements certain biological products or categories of biological products regulated under section 351 of the Public Health Service (PHS) Act if the Secretary determines that such reporting is not necessary to protect the public health. Agency regulations implementing drug establishment and registration provisions are found in part 207 (21 CFR part 207) and include reporting and recordkeeping requirements.
The information collection utilizes guidance documents intended to facilitate reporting and recordkeeping provided for by section 510 of the FD&C Act. All Agency guidance documents are issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time. To search available FDA guidance documents, visit the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Because FDA relies on establishment registration and drug listing information for several of its programs, complete, accurate, and up-to-date information is essential to FDA's role in ensuring public health.
Respondents to the collection of information are domestic establishments that manufacture, repack, relabel, or salvage a drug, or an animal feed bearing or containing a new animal drug, and foreign establishments that manufacture, repack, relabel, or salvage a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. As set forth in the applicable regulations, when operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments. Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.
Consistent with provisions in §?207.61 (21 CFR 207.61), except as provided in §?207.65 (21 CFR 207.65), all registration and listing information must be transmitted to FDA using FDA's electronic drug registration and listing system in an electronic format that we can process, review, and archive. For more information regarding FDA's Electronic Drug Registration and Listing System (eDRLS), including "Latest News" updates, we encourage respondents to visit our website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls. Updated daily, a registration database we also maintain that includes a publication of currently registered establishments is on our website at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
Since our last evaluation of the information collection, we have made the following modifications as a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136):
• The scope of activity for the information collection now reflects exemptions from reporting under section 510(j)(3) of the FD&C Act applicable to: (1) blood and blood components for transfusion and (2) cell and gene therapy products, where one lot treats a single patient, as announced in the Federal Register of April 13, 2023 (88 FR 22454) (April 2023 final order).
• We have added recommendations from the guidance document entitled "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products" (March 2011) (available at https://www.fda.gov/media/120092/download ), to the scope of activity included in the collection of information. The guidance document is intended to encourage manufacturers of drug and therapeutic biological products, and any raw materials and components used in those products, to develop a written Emergency Plan (Plan) for maintaining an adequate supply of medically necessary drug products during an emergency that results in high employee absenteeism. The guidance document discusses the elements that should be covered by such a Plan and recommends notifications to FDA's Center for Drug Evaluation and Research (CDER) when activating or deactivating a Plan.
• Section 510(j)(3) of the FD&C Act requires that registrants annually report the amount of each listed drug that they manufacture, prepare, propagate, compound, or process (hereinafter manufacture) for commercial distribution. Section 510(j)(3) of the FD&C Act also authorizes the Secretary to require that the information be reported in an electronic format as determined by the Secretary, and that it be reported at the time a public health emergency is declared. To provide instruction in this regard, we issued the guidance document entitled "Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act" (February 2024) (available at https://www.fda.gov/media/175933/download ). In addition to supporting FDA's response to drug shortages, the guidance document is also intended to facilitate FDA's access to information useful in making decisions regarding the appropriate level of drug facility surveillance.
• As we continue to receive similar information regarding animal drug shortages, we developed and issued the guidance document "Reporting and Mitigating Animal Drug Shortages" (Center for Veterinary Medicine GFI #271) (May 2023) (available at https://www.fda.gov/media/137722/download ). The guidance document is intended to assist respondents in notifying FDA about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of animal drugs.
[top] In the Federal Register of September 5, 2024 (89 FR 72403), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. On our own initiative however, we are noting some clarifications and modifications with regard to the information collection and
First, we have removed the information collection element exclusively attributable to the development of standard operating procedures for providing regulatory submissions in an electronic format. The requirement to submit registration and listing information to FDA electronically has been in effect for more than 10 years and is now standard business practice. We assume that most, if not all, respondents to the information collection now implement and utilize electronic data systems compatible with FDA and invite comment on our assumption. FDA uses a structured product labeling (SPL) standard to support submissions through our electronic submission gateway (ESG). On our website at https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources, we provide informational resources regarding the SPL format standard, including Agency guidance, intended to assist respondents with technological considerations in submitting regulatory information to FDA.
Additionally, CDER continues to develop and refine submission tools that utilize interactive data submission technology for a number of its programs. We believe most, if not all, respondents to the collection of information use these platforms to submit required drug registration and listing information and invite comment on our assumption.
We are also clarifying that submission of the unique facility identifier (UFI) and the accompanying data elements referenced in section 510(b), (c), and (i) of the FD&C Act is included among the scope of activity covered by the information collection. The procedural guidance document entitled "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration," (November 2014), explains that FDA's currently preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet. FDA has been using the DUNS number as a registration number for drug establishments since its implementation of electronic drug registration and listing. The guidance document is available for download from our website at https://www.fda.gov/media/89926/download.
FDA estimates the burden of this collection of information as follows:
| Collection activity; authority to collect information | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Initial establishment registration; §§?207.17, 207.21, and 207.25 | 593 | 2 | 1,186 | 1 | 1,186 |
| Annual review and update of registration information (including expedited updates); §?207.29 | 10,480 | 3 | 31,440 | 0.5 (30 minutes) | 15,720 |
| Initial listing (including National Drug Code (NDC)); §§?207.33, 207.41, 207.45, 207.49, 207.53, 207.54, and 207.55 | 3,040 | 7.28 | 22,130 | 1.5 | 33,197 |
| June and December review and update (or certification) of listing; §§?207.35 and 207.57 | 5,153 | 20 | 103,060 | 0.75 (45 minutes) | 77,295 |
| Waiver requests; §?207.65 | 1 | 1 | 1 | 0.5 (30 minutes) | 1 |
| Public disclosure exemption request; §?207.81(c) | 30 | 1 | 30 | 1 | 30 |
| Manufacturing amount information; FD&C Act section 510(j)(3) | 8,700 | 22.5 | 195,750 | 1 | 195,750 |
| Maintenance of, and notifications associated with, plans to ensure availability of medically necessary drug products during emergency; FDA topic-specific guidance, section III.F | 2 | 1 | 2 | 16 | 32 |
| Reporting and Mitigating Animal Drug Shortages; FDA topic-specific Guidance, section III | 30 | 2 | 60 | 1 | 60 |
| Total | 353,659 | 323,271 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Although we denote that table 1 reflects reporting activity, we include the retention and maintenance of corresponding records in our calculation and assessment of burden. While there are 10,480 establishments currently registered with FDA, registration and listing data is subject to frequent fluctuation as a result of the volume of activity.
Based on our experience with the information collection, we estimate 593 respondents will submit 1,186 new establishment registrations annually using the CDER Direct submission platform. We assume an average of 1 hour is necessary for this activity. Similarly, we estimate that 10,480 registrants will provide 31,440 annual reviews and updates of registration information (including expedited updates) or reviews and certifications that no changes have occurred. Our estimate includes the registration of establishments for both domestic and foreign manufacturers, repackers, relabelers, and drug product salvagers, and registration information submitted by anyone acting as an authorized agent for an establishment that manufactures, repacks, relabels, or salvages drugs. The estimate also includes an additional 80 positron emission tomography drug producers who are not exempt from registration and approximately 30 manufacturers of plasma derivatives. We assume 30 minutes is necessary for each annual review and update of registration information (including any expedited updates) or each review and certification that no changes have occurred.
[top] Although we have not received a request for waiver as provided for in §?207.65, we retain a placeholder of 1 for such activity and assume 30 minutes is necessary to prepare and make the submission. Relatedly, we reduced our estimate of requests for exemption from public disclosure the information submitted in accordance with §?207.81 from 100 to 30 to reflect a decrease of activity.
The reporting of manufacturing amount information under section 510(j)(3) of the FD&C Act is a new element to the information collection. We assume it takes 1 hour to prepare and submit the necessary reporting information and estimate an average of 22.5 reports will be submitted annually from 8,700 registrants. We exclude 1,780 respondents from the 10,480 registrants, (accounting for both biological product and drug product registrants) to reflect the reporting exemptions implemented under section 510(j)(3)(B). Also, based on informal communications, we have increased the estimate of burden we attribute to preparing and submitting the requisite information from 15 minutes to 1 hour.
Similarly, intending to ensure the availability of medically necessary drug products during emergencies that might result in high absenteeism at production facilities, we account for burden associated with the development of a manufacturing contingency plan as recommended in Agency guidance "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products," (March 2011), referenced above. We assume that most respondents have already developed a Plan as recommended by the guidance document as a usual and customary business practice, and limit therefore, our current burden estimate to updates, maintenance, and the reporting to FDA of the activation and deactivation of the Plan. We assume two notifications (for purposes of this analysis, we consider an activation and a deactivation notification to equal one notification) will be submitted to CDER annually, and estimate each notification requires an average of 16 hours to prepare and submit.
Finally, animal drug shortage information is also a new element to the information collection. Although not statutorily required, we estimate that 30 respondents will provide 2 notifications annually and that it will take 1 hour to prepare and submit each notification as recommended in the guidance document entitled "Reporting and Mitigating Animal Drug Shortages," referenced above.
Cumulatively, these adjustments and modifications result in a decrease of 67,004 responses and an increase of 87,413 burden hours, annually. We have removed burden we attributed to developing and implementing electronic data systems as we now regard this activity as usual and customary, however we have increased our estimate of the time needed for some of the activities to account for corresponding record maintenance.
Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30355 Filed 12-19-24; 8:45 am]
BILLING CODE 4164-01-P