Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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:

Fax written comments on the collection of information by November 12, 2019.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0827. Also include the FDA docket number found in brackets in the heading of this document.

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.

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910-0827—Extension

The Drug Quality and Security Act added section 503B to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) creating a category of entities called “outsourcing facilities.” Outsourcing facilities, as defined in section 503B(d)(4) of the FD&C Act, are facilities that must meet all the requirements described in section 503B, including registering with FDA as an outsourcing facility and submitting regular reports identifying the drugs compounded by the outsourcing facility during the previous 6-month period. The first of these reports must be submitted upon initial registration as an outsourcing facility. Thereafter, semiannual product reports must be submitted, once during the month of June and once during the month of December, for as long as an establishment remains registered as an outsourcing facility.

In addition, drug products compounded in an outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section 503B are met.

To help respondents understand the statutory requirements, how we interpret them, and the associated information collection, we developed the guidance document entitled “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The guidance is available from our website at: https://www.fda.gov/media/90173/download. The guidance explains that, once an entity has elected to register as an outsourcing facility, it must submit reports identifying the drugs compounded by the outsourcing facility. The guidance also communicates who must report, the format of the report, the content to include in each report, when to report, how reports are submitted to FDA, and the consequences of outsourcing facilities' failure to submit reports.

In the Federal Register of July 17, 2019 (84 FR 34184), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Based on current data for outsourcing facilities, we estimate that 75 outsourcing facilities will submit an initial report identifying all drugs compounded in the facility in the previous 6 months. For the purposes of this estimate, each product's structured product labeling (SPL) submission is considered a separate response, and therefore each facility's product report will include multiple responses. Taking into account that a particular product that is compounded into different strengths from different sources of active ingredient can be reported in a single SPL response, we estimate that each facility will average 76 products. Our estimate is based on current product reporting data.

We expect each product report will consist of multiple SPL responses per facility and estimate that preparing and submitting this information electronically may take up to 2 hours for each initial SPL response. We also estimate that the 75 registered outsourcing facilities will submit a report twice each year identifying all drugs compounded at the facility in the previous 6 months.

As stated above, we estimate on average 76 SPL responses per facility and that preparing and submitting this information electronically will take approximately 30 minutes per response. We have reduced our burden estimate for semiannual product submissions because outsourcing facilities can save each SPL 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 SPL response needs be sent for that product during that reporting period.

We expect to receive no more than one waiver request, each, from the electronic submission process for initial product reports and semiannual reports, and that each waiver request will take 1 hour to prepare and submit.

Based on submissions we have received, we have reduced the number of responses significantly since our original estimate establishing the collection. This results in an overall reduction to the information collection by 36,072 hours.