Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

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 requests comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.

DATES:

Submit either electronic or written comments on the collection of information by November 30, 2021.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 30, 2021. 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.

• 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-2019-N-3077 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities.” 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:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 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.

Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

OMB Control Number 0910-0883—Extension

This information collection supports FDA research in obtaining a range of information pertaining to human prescription drug compounding by outsourcing facilities. Generally, drug compounding is the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored an individual patient's needs. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, compounded drugs also present a risk to patients. Compounded drugs are not FDA-approved; therefore, they do not undergo FDA premarket review for safety, effectiveness, and quality. Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be satisfied for compounded human prescription drug products to be exempt from certain sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (current good manufacturing practice (CGMP) requirements), (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate directions for use), and (3) section 505 (21 U.S.C. 355) (approval of drugs under new drug applications or abbreviated new drug applications).

The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created outsourcing facilities—a new industry sector of drug compounders held to higher quality standards to protect patient health. Section 503B of the FD&C Act (21 U.S.C. 353b) describes the conditions that outsourcing facilities must satisfy for drug products compounded in an outsourcing facility by or under the direct supervision of a licensed pharmacist to be exempt from the certain sections of the FD&C Act. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs that hospitals, clinics, and other providers need.

FDA continues to find concerning quality and safety problems during inspections of outsourcing facilities. FDA has implemented and will continue to implement programs to support compounding quality and compliance. One initiative is FDA's Compounding Quality Center of Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence,, which was developed to focus on improving the quality of compounded human prescription drugs to promote patient safety. One of our top priorities is to help ensure that compounded drugs are safe by focusing on quality. FDA, state regulators, pharmacy associations, and compounders, including outsourcing facilities, share the responsibility of patient safety.

The Center of Excellence engages and collaborates with compounders, including outsourcing facilities, and other stakeholders to improve the overall quality of compounded drugs. Furthermore, the Center of Excellence promotes collaboration to help compounders implement robust quality management systems that are better for business and the safety of patients.

To help strengthen the outsourcing facility industry's ability to provide quality compounded drugs to patients who need them, the Center of Excellence offers training sessions and opportunities to develop manufacturing quality and other policies for outsourcing facilities, including CGMPs.

The Center of Excellence offers several training sessions (available at https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs ). Self-guided training sessions teach the following topics: (1) Environmental monitoring, (2) sterile drug compounding, (3) cleanroom performance tests, and (4) conducting investigations and formulating corrective and preventive actions. Instructor-led sessions teach the regulatory framework for these topics: (1) Human drug compounding, (2) airflow practices, (3) insanitary conditions and sterility, (4) stability and beyond use dates, (5) requirements for outsourcing facility guides, and (6) conducting investigations and formulating corrective and preventive actions. Management and staff from outsourcing facilities have attended the training sessions. Feedback on the training sessions has been positive, and interest in the sessions continues to grow.

In addition, the Center of Excellence is conducting indepth research to better understand outsourcing facilities' challenges and opportunities in different areas to help guide decisions regarding future training and other engagement. Outsourcing facilities encounter the following challenges and opportunities: (1) Operational barriers and opportunities related to the outsourcing facility market and business viability, (2) knowledge and operational barriers and opportunities related to compliance with Federal policies and good quality drug production, and (3) barriers and opportunities related to outsourcing facility interactions with FDA.

FDA used previous research results under this information collection to develop an understanding of the outsourcing facility sector, the sector's challenges, and opportunities for advancement. The information collected was an essential tool to help FDA identify knowledge and information gaps, operational barriers, and views on interactions with FDA. FDA has presented this information in public settings such as stakeholder meetings. Continuing this collection will enable FDA to deepen our understanding of the outsourcing facility sector and increase our efficacy in developing a Center of Excellence that is responsive to outsourcing facilities' needs. The research results will inform FDA's future activities for the Center of Excellence in the areas of communication, education, training, and other engagement with outsourcing facilities to address challenges and support advancement.

Researchers engage with pharmacists, staff, and management from outsourcing facilities and similar compounding businesses and may use surveys, interviews, and focus groups to obtain information about outsourcing facilities' challenges and opportunities. Within this context, we may pose the following questions or similar, related questions:

1. What financial and operational considerations inform outsourcing facility operational and business model decisions?

2. What factors impact developing a sustainable outsourcing facility business?

3. What financial and operational considerations inform outsourcing facility product decisions?

4. Do outsourcing facilities understand the Federal laws and policies that apply to them? What, if any, knowledge gaps do we need to address?

5. What are outsourcing facilities' challenges when implementing Federal CGMP requirements?

6. How do outsourcing facilities implement quality practices at their facilities?

7. How do outsourcing facilities develop CGMP and quality expertise? How do they obtain this knowledge, and what training do they need?

8. What are the economic consequences of CGMP noncompliance and product failures for outsourcing facilities?

9. What are outsourcing facility management and staff views on current interactions with FDA? How do they want the interactions to change?

10. What are outsourcing facilities' understanding of how to engage with FDA during and following an inspection?

FDA estimates the burden of this collection of information as follows:

Our original request for the information collection was approved January 21, 2020; however, the subsequent public health emergency inhibited our ability to administer the requested survey. We have therefore made no adjustments to our current burden estimate.