87 FR 117 pgs. 36507-36509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type: NOTICEVolume: 87Number: 117Pages: 36507 - 36509
Pages: 36507, 36508, 36509Docket number: [Docket No. FDA-2015-N-0030]
FR document: [FR Doc. 2022-13068 Filed 6-16-22; 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-2015-N-0030]
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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 electronic reporting for outsourcing facilities.
DATES:
Submit either electronic or written comments on the collection of information by August 16, 2022.
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 16, 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.
[top] • 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-2015-N-0030 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act." 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:
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:
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.
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0800-Revision
This information collection helps support implementation of sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the Federal Food Drug and Cosmetic Act (FD&C Act), which govern requirements for pharmacy compounding and outsourcing facilities, respectively. For efficiency of Agency operations, we are revising the information collection to include related reporting activities currently approved under OMB control number 0910-0827. Specifically, upon electing and in order to become an outsourcing facility, respondents must register under section 503B of the FD&C Act and submit certain reports and updates to FDA. The information is required to be submitted by electronic means unless otherwise exempt, and prepared in such form and manner as the Secretary of the Department of Health and Human Services may prescribe through regulation or guidance. In the guidance for industry "Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act," (December 2016) available on our website at https://www.fda.gov/media/90173/download, we explain how facilities that elect to register with FDA as outsourcing facilities are to submit drug product reports, consistent with section 503B of the FD&C Act. The guidance document describes who must report and what information must be provided to FDA. The guidance document also explains that drug compounding reports must be submitted in structured product labeling (SPL) format using FDA's electronic submissions system, and discusses the consequences of outsourcing facilities' failure to submit reports.
We estimate the burden of this collection of information as follows:
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| Section 503B of the FD&C act | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Initial product reports | 3 | 53 | 159 | 0.0833 (5 minutes) | 13.25 |
| Waiver request from electronic submission of initial product reports | 1 | 1 | 1 | 1 | 1 |
| June product reports | 75 | 53 | 3,975 | 0.025 (1.5 minutes) | 99.375 |
| December product reports | 75 | 53 | 3,975 | 0.025 (1.5 minutes) | 99.375 |
| Waiver request from electronic submission of product reports | 1 | 1 | 1 | 1 | 1 |
| Total | 214 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Respondents to this collection of information are outsourcing facilities. Based upon our evaluation of the information collection, we have adjusted our estimate downward by 16 hours (from 230 to 214) annually to reflect more recent data. We estimate that each year three outsourcing facilities will submit a product report upon initial registration under section 503B of the FD&C Act. We estimate that twice each year 75 outsourcing facilities will submit a report identifying all human drugs compounded in the facility in the previous 6 months. For the purposes of this estimate, each product's SPL submission is considered a separate product response, and therefore each facility's product report will include multiple product responses. We estimate that each facility will average 53 product responses. We expect each product report will consist of multiple product responses per facility and estimate that preparing and submitting this information electronically may take up to 5 minutes for each initial product response.
Assuming an average of 53 product responses per facility, we estimate that, for semiannual reports, preparing and submitting this information electronically will take 1.5 minutes per product response. Our burden estimate for semiannual product report submissions is lower than for initial product reports because outsourcing facilities can save each product response once initially created and submitted. For subsequent reports, an outsourcing facility may resubmit the same file(s) after changing the RootID and version number (both SPL metadata), effective date (to identify the reporting period), and the number of units produced, along with other data as appropriate, to appropriate values for the reporting period. Furthermore, if a product was not compounded during a particular reporting period, no product response would be sent for that product during that reporting period.
We expect to receive no more than one waiver request from the electronic submission process for initial product reports and semiannual reports, and that each waiver request will take 60 minutes to prepare and submit.
Dated: June 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13068 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P