Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-3762]</DEPDOC> <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by June 2, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> 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 0910-0883. Also include the FDA docket number found in brackets in the heading of this document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities</HD> <HD SOURCE="HD2">OMB Control Number 0910-0883—Extension</HD> This information collection supports FDA research to obtain information about challenges and opportunities 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 to 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) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (current good manufacturing practice (CGMP) requirements); (2) section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate directions for use); and (3) section 505 of the FD&C Act (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), <E T="03">https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was</E> 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. In addition, the Center of Excellence is conducting in depth 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. We revised the survey to improve clarity and simplify the experience for participants. We made grammatical, stylistic, format, and other editorial changes to the content. In doing so, we reduced the number of questions from 31 to 20. We anticipate a reduction in burden hours to 30 minutes (.50 hour) per survey response from our previous estimate of 1 hour per response. Researchers engage with pharmacists, staff, and management from outsourcing facilities and similar compounding businesses, and related stakeholders and use surveys 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? Respondents to this information collection are employees at outsourcing facilities and related human prescription drug compounding businesses. In the <E T="04">Federal Register</E> of September 5, 2024 (89 FR 72410), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received four comment letters from trade organizations and industry, each containing one or more comments on the proposed collection of information. (Comment 1) Several comments expressed appreciation for FDA's efforts in developing a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. Other comments expressed appreciation for FDA's efforts to ensure that the survey questions capture the most important information from compounding outsourcing facilities and that the survey not place an undue burden on respondents. (Response 1) We agree that the information being collected has utility for understanding of the outsourcing facility sector, its challenges, and opportunities for advancement and that we are making an effort to not place an undue burden on respondents. (Comment 2) One comment suggested that certain questions focus on financial considerations and economic consequences and argued that they are not necessary for FDA's oversight of outsourcing facilities and are unrelated to FDA's public health mission and the qualit ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 13k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━