Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, 22674-22678 [2021-08943]

Download as PDF 22674 Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices The number of respondents for each CFR section in table 3 was identified from the MDRs reported to FDA’s internal databases during the period recently. Based on a review of the information collection since our last request for OMB approval, we have made no changes to our burden estimate. Dated: April 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–08962 Filed 4–28–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0359] Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) 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 information collection associated with Agency guidance documents pertaining to pharmacies, outsourcing facilities, and other entities with regard to human drug compounding, repackaging, and related activities. DATES: Submit either electronic or written comments on the collection of information on or before June 28, 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 June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 28, 2021. Comments jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Apr 28, 2021 Jkt 253001 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– 2021–N–0359 for ‘‘Human Drug Compounding, Repackaging, and Related Activities Regarding 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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-201509-18/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. E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices 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 additional 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 additional 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, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910–0858— Revision This information collection supports implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by pharmacies, outsourcing facilities, and other entities. Compounding is generally a practice in 22675 which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present risks to patients. Our compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Respondents to the information collection are pharmacies, outsourcing facilities, and other entities. To assist respondents in complying with statutory requirements, we have issued the following topic-specific guidance documents: TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT Title Notice of availability publication date jbell on DSKJLSW7X2PROD with NOTICES Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (‘‘Radiopharmaceutical Compounding and Repackaging Guidance’’). Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (‘‘Radiopharmaceutical Outsourcing Repackaging Guidance’’). Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (‘‘Repackaging Guidance’’). Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (‘‘Biologics Guidance’’). These guidance documents were issued consistent with our Good Guidance Practice regulations in 21 CFR part 10.115 which provide for public comment at any time. The guidance documents communicate our current thinking on the respective topics and include information collection that may result in expenditures of time and effort by respondents. In our notices of availability we also solicited public comment under the PRA on the information collection provisions. FDA has developed and maintains a searchable guidance database available at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Guidance documents covered by this information collection may be found by choosing ‘‘Center for Drug Evaluation and Research’’ from among the FDA Organizations, and by selecting the term ‘‘Compounding’’ from among the possible Filters.1 For 1 Guidance documents applicable to animal drug compounding regulated by our Center for Veterinary Medicine would also be returned if no FDA Organization is selected; this information VerDate Sep<11>2014 18:32 Apr 28, 2021 Jkt 253001 efficiency of operations we are consolidating the related information collections. Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities Because Congress explicitly excluded radiopharmaceuticals from section 503A of the FD&C Act (see section 503A(d)(2)), compounded radiopharmaceuticals are not eligible for the exemptions under section 503A from section 505 of the FD&C Act (21 U.S.C. 355) (concerning new drug approval requirements), section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning labeling with adequate directions for use), and section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)B)) (concerning current good manufacturing practice (CGMP) requirements). In addition, the FD&C Act does not provide an exemption for collection covers only those Compounding documents issued by the Center for Drug Evaluation and Research. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 September 26, 2018 (83 FR 48633). September 26, 2018 (83 FR 48630). January 13, 2017 (82 FR 4343). January 19, 2018 (83 FR 2787). repackaged radiopharmaceuticals. This guidance document describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-licensed nuclear pharmacy, Federal facility, or other facility that is not an outsourcing facility and that holds a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State compounds or repackages radiopharmaceuticals for human use. The guidance explains that one condition is that the compounded radiopharmaceutical is not essentially a copy of an approved radiopharmaceutical. As described in the guidance, FDA does not intend to consider a compounded radiopharmaceutical to be essentially a copy if, among other reasons, there is a change between the compounded radiopharmaceutical and the approved radiopharmaceutical that produces a clinical difference for an identified individual patient, as determined by the prescribing practitioner and E:\FR\FM\29APN1.SGM 29APN1 22676 Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES documented in writing on the prescription or order. In addition, FDA does not intend to consider a compounded radiopharmaceutical to be essentially a copy if the FDA-approved radiopharmaceutical is on FDA’s drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of compounding and distribution. If the facility compounded a drug that is identical or nearly identical to an approved drug product that appeared on FDA’s drug shortage list, the facility should maintain documentation (e.g., a notation on the order for the compounded drug) regarding the status of the drug on FDA’s drug shortage list at the time of compounding, distribution, and dispensing. Radiopharmaceutical Outsourcing Repackaging Guidance In contrast to section 503A, section 503B of the FD&C Act does not exclude radiopharmaceuticals. Therefore, FDA’s overall policies regarding section 503B apply to the compounding of radiopharmaceutical drug products. However, we have developed specific policies that apply only to the compounding of radiopharmaceuticals by outsourcing facilities using bulk drug substances and to the compounding of radiopharmaceuticals by outsourcing facilities that are essentially copies of approved drugs when such compounding is limited to minor deviations, as that term is defined in the guidance. FDA issued this guidance in part to describe the conditions under which the Agency does not generally intend to take action for violations of sections 505 and 502(f)(1) of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals for human use. As discussed in the guidance, one condition is that if a radiopharmaceutical is repackaged by an outsourcing facility, the label on the immediate container (primary packaging, e.g., the syringe) of the repackaged product includes certain information. The guidance also provides that the label on the container from which the individual units are removed for administration (secondary packaging, e.g., the bag, box, or other package in which the repackaged products are distributed) includes: (1) The active and inactive ingredients, if the immediate product label is too small to include this information, and directions for use, including (as appropriate) dosage and administration and (2) the following information to facilitate adverse event reporting: https://www.fda.gov/medwatch and 1– 800–FDA–1088. VerDate Sep<11>2014 18:32 Apr 28, 2021 Jkt 253001 Repackaging Guidance This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505 (concerning new drug applications), 502(f)(1) (concerning labeling with adequate directions for use), 582 ((21 U.S.C. 360eee-1) concerning drug supply chain security requirements), and (where specified in the guidance) section 501(a)(2)(B) of the FD&C Act (concerning CGMPs), when a state-licensed pharmacy, Federal facility, or outsourcing facility repackages certain prescription drug products. One condition discussed in the guidance is that if a drug is repackaged by an outsourcing facility, the label on the immediate container (primary packaging, e.g., the syringe) of the repackaged product includes certain information described in the guidance. Another condition discussed in the guidance is that the label on the container from which the individual units are removed for administration (secondary packaging, e.g., the bag, box, or other package in which the repackaged products are distributed) includes: (1) The active and inactive ingredients, if the immediate product label is too small to include this information, and directions for use, including (as appropriate) dosage and administration, (2) directions for use, including, as appropriate, dosage and administration, and (3) the following information to facilitate adverse event reporting: https://www.fda.gov/ medwatch and 1–800–FDA–1088. Biologics Guidance Certain licensed biological products may sometimes be mixed, diluted, or repackaged in a way not described in the approved labeling for the product to meet the needs of a specific patient. As described in the guidance, biological products subject to licensure under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262) are not eligible for the statutory exemptions available to certain compounded drugs under sections 503A and 503B of the FD&C Act. In addition, a biological product that is mixed, diluted, or repackaged outside the scope of an approved Biologics License Application (BLA) is considered an unlicensed biological product under section 351 of the PHS Act. This guidance document describes several conditions under which FDA does not intend to take action for violations of section 351 of the PHS Act and sections 502(f)(1), 582, and (where specified) 501(a)(2)(B) of the FD&C Act, when a State-licensed pharmacy, a PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Federal facility, or an outsourcing facility dilutes, mixes, or repackages certain biological products outside the scope of an approved BLA. One condition discussed in the guidance is that if the labeling for the licensed biological product includes storage instructions, handling instructions, or both (for example, protect from light, do not freeze, keep at specified storage temperature), the labeling for the biological product that is mixed, diluted, or repackaged specifies the same storage conditions. Another condition described in the guidance is that, if the biological product is mixed, diluted, or repackaged by an outsourcing facility, the label on the immediate container (primary packaging, for example, the syringe) of the mixed, diluted, or repackaged product includes certain information described in the guidance. In addition, the guidance communicates that as a condition for biological products mixed, diluted, or repackaged by an outsourcing facility that, if the immediate product label is too small to bear the active and inactive ingredients, such information is included on the label of the container from which the individual units are removed for administration (secondary packaging, for example, the bag, box, or other package in which the mixed, diluted, or repackaged biological products are distributed). The guidance also communicates our thinking about the condition for biological products mixed, diluted, or repackaged by an outsourcing facility that the label on the container from which the individual units are removed for administration include directions for use. These directions include, as appropriate, the dosage and administration and the following information to facilitate adverse event reporting: https://www.fda.gov/ medwatch and 1–800–FDA–1088. Finally, another condition described in the guidance is that outsourcing facilities maintain records of the testing performed in accordance with ‘‘Appendix A—Assigning a BUD for Repackaged Biological Products Based On Stability Testing’’ of the guidance for biological products repackaged by outsourcing facilities for which the beyond use date (BUD) is established based on a stability program conducted in accordance with Appendix A. Section III.C of the guidance, ‘‘Licensed Allergenic Extracts for Subcutaneous Immunotherapy,’’ discusses the preparation of prescription sets (that is, licensed allergenic extracts that are mixed and diluted to provide subcutaneous E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices immunotherapy to an individual patient) by a physician, a State-licensed pharmacy, a Federal facility, or an outsourcing facility. Another condition described in the guidance is that if the prescription set is prepared by an outsourcing facility, the label of the container from which the individual units of the prescription set are removed for administration (secondary packaging) includes the following information to facilitate adverse event reporting: https://www.fda.gov/ medwatch and 1–800–FDA–1088. Each 22677 prescription set prepared by an outsourcing facility is also accompanied by instructions for use. We estimate the burden of this information collection as follows: TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of disclosures per respondent Number of respondents Activity Total annual disclosures Average burden per disclosure Total hours Radiopharmaceutical Guidance Consultation between the compounder and prescriber and the notation on the prescription or order documenting the prescriber’s determination of clinical difference. 10 25 250 .05 (3 minutes) ....... 12.5 Radiopharmaceutical Outsourcing and Repackaging Guidance Designing, testing, and producing each label on immediate containers, packages and/or outer containers. 2 5 10 0.5 (30 minutes) ..... 5 6 21 126 1 ............................. 126 6 2 12 3 ............................. 24 Repackaging Guidance Designing, testing, and producing each label on immediate containers, packages, and/or outer containers. Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (Guidance Section III.A.). Biologics Guidance Designing, testing, and producing the label, container, packages, and/or outer containers for each mixed, diluted, or repackaged biological product. Designing, testing, and producing each label on immediate containers, packages and/or outer containers for each licensed allergenic extract. Maintaining records of testing performed in accordance with Biologics Guidance Appendix A. 15 5 75 0.5 (30 minutes) ..... 37.5 5 300 1,500 0.5 (30 minutes) ..... 750 5 30 150 0.083 (5 minutes) ... 12.5 Total .................................................................... ........................ .......................... 2,123 ................................ 967.5 jbell on DSKJLSW7X2PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. As defined in 44 U.S.C. 3502(13), the term ‘‘recordkeeping requirement’’ means a requirement imposed on respondents to maintain specified records, as well as a requirement to ‘‘retain such records; notify third parties, the Federal Government, or the public of the existence of such records; disclose such records to third parties, the Federal Government, or the public; or report to third parties, the Federal Government, or the public regarding such records.’’ For purposes of our analysis, therefore, we have characterized the burden associated with the time and effort expended on the information collection recommendations discussed in the respective guidance documents as recordkeeping activities. At the same time, our findings show that compliance VerDate Sep<11>2014 18:32 Apr 28, 2021 Jkt 253001 with recordkeeping requirements applicable to compounded and repackaged drug products is standard practice in the compounding and selling of these drug products under States’ pharmacy laws and other State laws governing recordkeeping by healthcare professionals and healthcare facilities. We have therefore excluded from our estimate recordkeeping practices discussed in the respective guidance documents we consider usual and customary. We invite comment on this assumption. identified individual patient as compared to the comparable approved radiopharmaceutical. We estimate that those compounders will document this determination on 250 prescriptions or orders for compounded radiopharmaceuticals. We assume consultation between the compounder and the prescriber and noting this determination on each prescription or order that does not already document this determination will take 3 minutes (0.05 hours) per prescription or order, for a total of approximately 12.5 hours. Radiopharmaceutical Compounding and Repackaging Guidance We estimate 10 compounders annually will consult a prescriber to determine whether a compounded radiopharmaceutical has a change that produces a clinical difference for an Radiopharmaceutical Outsourcing and Repackaging Guidance We estimate a total of 2 outsourcing facilities annually will each design, test, and produce an average of 5 different labels for a total of 10 labels, as described in the guidance (including PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1 22678 Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices directions for use). We assume that designing, testing, and producing each label will take 30 minutes (0.5 hours) for each repackaged radiopharmaceutical, for a total of 5 hours. We consider that the provision to include ‘‘https:// www.fda.gov/medwatch’’ and ‘‘1–800– FDA–1088’’ is not a collection of information as defined in 5 CFR 1320.3(c)(2) and is therefore exempt from OMB review and approval under the PRA. jbell on DSKJLSW7X2PROD with NOTICES Repackaging Guidance Based on current data for outsourcing facilities, we estimate 6 outsourcing facilities annually will submit an initial report identifying all drugs repackaged in the facility in the previous year. 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 repackaged may come in different strengths and can be reported in a single SPL response, we estimate that each facility will average approximately 6 products. Similarly, we estimate that 6 outsourcing facilities will submit an initial report identifying all drugs repackaged in the facility in the past year. Taking into account that a particular product that is repackaged may come in different strengths and can be reported in a single SPL response, we assume that each facility will average 6 products. Our estimate is based on current product reporting data. We expect that each product report will consist of multiple SPL responses per facility and assume preparing and electronically submitting this information will take up to 2 hours for each initial SPL response. We also estimate 3 registered outsourcing facilities will submit a report twice each year (June and December) that identifies all drugs repackaged at the facility in the previous 6 months. We also estimate that an average of 3 facilities will prepare and submit 3 SPL responses and assume that preparing and submitting this information electronically will take 2 hours per response. If a product was not repackaged during a particular reporting period, outsourcing facilities do not need to send an SPL response for that product during that reporting period. We expect to receive no waiver requests from the electronic submission process for initial product reports and semiannual reports. VerDate Sep<11>2014 18:32 Apr 28, 2021 Jkt 253001 Biologics Guidance We estimate 15 outsourcing facilities annually who mix, dilute, or repackage biological products will each design, test, and produce 5 different labels, for a total of 75 labels that include the information set forth in section III.B— ‘‘Mixing, Diluting, or Repackaging Licensed Biological Products’’ of the guidance (including directions for use) as well as inclusion of storage instructions, handling instructions, or both. We assume that designing, testing, and producing each label will take 30 minutes (0.5 hours). We consider that the provision to include ‘‘https:// www.fda.gov/medwatch’’ and ‘‘1–800– FDA–1088’’ is not a collection of information as defined in 5 CFR 1320.3(c)(2) and is therefore exempt from OMB review and approval under the PRA. We estimate that annually a total of 5 outsourcing facilities who prepare prescription sets will each include on the labels, packages, and/or containers of approximately 300 prescription sets the information set forth in section III.C ‘‘Licensed Allergenic Extracts for Subcutaneous Immunotherapy’’ of the draft guidance (including directions for use), for a total of 1,500 disclosures. We assume the initial process of designing, testing, and producing labeling and attaching to each prescription set each label, package, and/or container will take approximately 30 minutes (0.5 hours), for a total of approximately 750 hours. Finally, we estimate that annually five outsourcing facilities who repackage biological products and establish a BUD in accordance with Appendix A— ‘‘Assigning a BUD for Repackaged Biological Products Based On Stability Testing’’ will maintain 150 records of the testing, as described in Appendix A of the guidance. We assume maintaining the records will take 5 minutes per record, for a total of 12.5 hours. Our estimated burden for the information collection reflects program changes and adjustments. We are changing the scope of the information collection to include burden attendant to provisions found in the Agency guidance documents discussed in this notice and have adjusted our estimate to reflect a resulting increase of 955 hours and 1,873 responses annually. Dated: April 20, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–08943 Filed 4–28–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 055’’ (Recognition List Number: 055), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable April 29, 2021. ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows: SUMMARY: 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 E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22674-22678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0359]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Drug Compounding, Repackaging, and Related 
Activities Regarding Sections 503A and 503B of the Federal Food, Drug, 
and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection associated with 
Agency guidance documents pertaining to pharmacies, outsourcing 
facilities, and other entities with regard to human drug compounding, 
repackaging, and related activities.

DATES: Submit either electronic or written comments on the collection 
of information on or before June 28, 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 June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 28, 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-2021-N-0359 for ``Human Drug Compounding, Repackaging, and Related 
Activities Regarding 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, 
[email protected].

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.

[[Page 22675]]

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 additional 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 
additional 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, Repackaging, and Related Activities Regarding 
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910-0858--Revision

    This information collection supports implementation of sections 
503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 353a and 21 U.S.C. 353b), which govern compounding by 
pharmacies, outsourcing facilities, and other entities. Compounding is 
generally a practice in which a licensed pharmacist, a licensed 
physician, or, in the case of an outsourcing facility, a person under 
the supervision of a licensed pharmacist, combines, mixes, or alters 
ingredients of a drug to create a medication tailored to the needs of 
an individual patient. Although compounded drugs can serve an important 
medical need for certain patients, they also present risks to patients. 
Our compounding program aims to protect patients from unsafe, 
ineffective, and poor quality compounded drugs, while preserving access 
to lawfully-marketed compounded drugs for patients who have a medical 
need for them. Respondents to the information collection are 
pharmacies, outsourcing facilities, and other entities.
    To assist respondents in complying with statutory requirements, we 
have issued the following topic-specific guidance documents:

             Table 1--Published Guidance Documents Regarding Sections 503A and 503B of the FD&C Act
----------------------------------------------------------------------------------------------------------------
                       Title                                   Notice of availability publication date
----------------------------------------------------------------------------------------------------------------
Compounding and Repackaging of                      September 26, 2018 (83 FR 48633).
 Radiopharmaceuticals by State-Licensed Nuclear
 Pharmacies, Federal Facilities, and Certain Other
 Entities (``Radiopharmaceutical Compounding and
 Repackaging Guidance'').
Compounding and Repackaging of                      September 26, 2018 (83 FR 48630).
 Radiopharmaceuticals by Outsourcing Facilities
 (``Radiopharmaceutical Outsourcing Repackaging
 Guidance'').
Repackaging of Certain Human Drug Products by       January 13, 2017 (82 FR 4343).
 Pharmacies and Outsourcing Facilities
 (``Repackaging Guidance'').
Mixing, Diluting, or Repackaging Biological         January 19, 2018 (83 FR 2787).
 Products Outside the Scope of an Approved
 Biologics License Application (``Biologics
 Guidance'').
----------------------------------------------------------------------------------------------------------------

    These guidance documents were issued consistent with our Good 
Guidance Practice regulations in 21 CFR part 10.115 which provide for 
public comment at any time. The guidance documents communicate our 
current thinking on the respective topics and include information 
collection that may result in expenditures of time and effort by 
respondents. In our notices of availability we also solicited public 
comment under the PRA on the information collection provisions. FDA has 
developed and maintains a searchable guidance database available at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Guidance documents covered by this information collection 
may be found by choosing ``Center for Drug Evaluation and Research'' 
from among the FDA Organizations, and by selecting the term 
``Compounding'' from among the possible Filters.\1\ For efficiency of 
operations we are consolidating the related information collections.
---------------------------------------------------------------------------

    \1\ Guidance documents applicable to animal drug compounding 
regulated by our Center for Veterinary Medicine would also be 
returned if no FDA Organization is selected; this information 
collection covers only those Compounding documents issued by the 
Center for Drug Evaluation and Research.
---------------------------------------------------------------------------

Compounding and Repackaging of Radiopharmaceuticals by State-Licensed 
Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
    Because Congress explicitly excluded radiopharmaceuticals from 
section 503A of the FD&C Act (see section 503A(d)(2)), compounded 
radiopharmaceuticals are not eligible for the exemptions under section 
503A from section 505 of the FD&C Act (21 U.S.C. 355) (concerning new 
drug approval requirements), section 502(f)(1) of the FD&C Act (21 
U.S.C. 352(f)(1)) (concerning labeling with adequate directions for 
use), and section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)B)) 
(concerning current good manufacturing practice (CGMP) requirements). 
In addition, the FD&C Act does not provide an exemption for repackaged 
radiopharmaceuticals. This guidance document describes the conditions 
under which FDA does not intend to take action for violations of 
sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-
licensed nuclear pharmacy, Federal facility, or other facility that is 
not an outsourcing facility and that holds a radioactive materials 
license for medical use issued by the Nuclear Regulatory Commission or 
by an Agreement State compounds or repackages radiopharmaceuticals for 
human use. The guidance explains that one condition is that the 
compounded radiopharmaceutical is not essentially a copy of an approved 
radiopharmaceutical. As described in the guidance, FDA does not intend 
to consider a compounded radiopharmaceutical to be essentially a copy 
if, among other reasons, there is a change between the compounded 
radiopharmaceutical and the approved radiopharmaceutical that produces 
a clinical difference for an identified individual patient, as 
determined by the prescribing practitioner and

[[Page 22676]]

documented in writing on the prescription or order. In addition, FDA 
does not intend to consider a compounded radiopharmaceutical to be 
essentially a copy if the FDA-approved radiopharmaceutical is on FDA's 
drug shortage list (see section 506E of the FD&C Act (21 U.S.C. 356e)) 
at the time of compounding and distribution. If the facility compounded 
a drug that is identical or nearly identical to an approved drug 
product that appeared on FDA's drug shortage list, the facility should 
maintain documentation (e.g., a notation on the order for the 
compounded drug) regarding the status of the drug on FDA's drug 
shortage list at the time of compounding, distribution, and dispensing.
Radiopharmaceutical Outsourcing Repackaging Guidance
    In contrast to section 503A, section 503B of the FD&C Act does not 
exclude radiopharmaceuticals. Therefore, FDA's overall policies 
regarding section 503B apply to the compounding of radiopharmaceutical 
drug products. However, we have developed specific policies that apply 
only to the compounding of radiopharmaceuticals by outsourcing 
facilities using bulk drug substances and to the compounding of 
radiopharmaceuticals by outsourcing facilities that are essentially 
copies of approved drugs when such compounding is limited to minor 
deviations, as that term is defined in the guidance. FDA issued this 
guidance in part to describe the conditions under which the Agency does 
not generally intend to take action for violations of sections 505 and 
502(f)(1) of the FD&C Act when an outsourcing facility repackages 
radiopharmaceuticals for human use.
    As discussed in the guidance, one condition is that if a 
radiopharmaceutical is repackaged by an outsourcing facility, the label 
on the immediate container (primary packaging, e.g., the syringe) of 
the repackaged product includes certain information. The guidance also 
provides that the label on the container from which the individual 
units are removed for administration (secondary packaging, e.g., the 
bag, box, or other package in which the repackaged products are 
distributed) includes: (1) The active and inactive ingredients, if the 
immediate product label is too small to include this information, and 
directions for use, including (as appropriate) dosage and 
administration and (2) the following information to facilitate adverse 
event reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088.
Repackaging Guidance
    This guidance describes the conditions under which FDA does not 
intend to take action for violations of sections 505 (concerning new 
drug applications), 502(f)(1) (concerning labeling with adequate 
directions for use), 582 ((21 U.S.C. 360eee-1) concerning drug supply 
chain security requirements), and (where specified in the guidance) 
section 501(a)(2)(B) of the FD&C Act (concerning CGMPs), when a state-
licensed pharmacy, Federal facility, or outsourcing facility repackages 
certain prescription drug products. One condition discussed in the 
guidance is that if a drug is repackaged by an outsourcing facility, 
the label on the immediate container (primary packaging, e.g., the 
syringe) of the repackaged product includes certain information 
described in the guidance.
    Another condition discussed in the guidance is that the label on 
the container from which the individual units are removed for 
administration (secondary packaging, e.g., the bag, box, or other 
package in which the repackaged products are distributed) includes: (1) 
The active and inactive ingredients, if the immediate product label is 
too small to include this information, and directions for use, 
including (as appropriate) dosage and administration, (2) directions 
for use, including, as appropriate, dosage and administration, and (3) 
the following information to facilitate adverse event reporting: 
https://www.fda.gov/medwatch and 1-800-FDA-1088.
Biologics Guidance
    Certain licensed biological products may sometimes be mixed, 
diluted, or repackaged in a way not described in the approved labeling 
for the product to meet the needs of a specific patient. As described 
in the guidance, biological products subject to licensure under section 
351 of the Public Health Service (PHS) Act (42 U.S.C. 262) are not 
eligible for the statutory exemptions available to certain compounded 
drugs under sections 503A and 503B of the FD&C Act. In addition, a 
biological product that is mixed, diluted, or repackaged outside the 
scope of an approved Biologics License Application (BLA) is considered 
an unlicensed biological product under section 351 of the PHS Act.
    This guidance document describes several conditions under which FDA 
does not intend to take action for violations of section 351 of the PHS 
Act and sections 502(f)(1), 582, and (where specified) 501(a)(2)(B) of 
the FD&C Act, when a State-licensed pharmacy, a Federal facility, or an 
outsourcing facility dilutes, mixes, or repackages certain biological 
products outside the scope of an approved BLA.
    One condition discussed in the guidance is that if the labeling for 
the licensed biological product includes storage instructions, handling 
instructions, or both (for example, protect from light, do not freeze, 
keep at specified storage temperature), the labeling for the biological 
product that is mixed, diluted, or repackaged specifies the same 
storage conditions. Another condition described in the guidance is 
that, if the biological product is mixed, diluted, or repackaged by an 
outsourcing facility, the label on the immediate container (primary 
packaging, for example, the syringe) of the mixed, diluted, or 
repackaged product includes certain information described in the 
guidance. In addition, the guidance communicates that as a condition 
for biological products mixed, diluted, or repackaged by an outsourcing 
facility that, if the immediate product label is too small to bear the 
active and inactive ingredients, such information is included on the 
label of the container from which the individual units are removed for 
administration (secondary packaging, for example, the bag, box, or 
other package in which the mixed, diluted, or repackaged biological 
products are distributed).
    The guidance also communicates our thinking about the condition for 
biological products mixed, diluted, or repackaged by an outsourcing 
facility that the label on the container from which the individual 
units are removed for administration include directions for use. These 
directions include, as appropriate, the dosage and administration and 
the following information to facilitate adverse event reporting: 
https://www.fda.gov/medwatch and 1-800-FDA-1088.
    Finally, another condition described in the guidance is that 
outsourcing facilities maintain records of the testing performed in 
accordance with ``Appendix A--Assigning a BUD for Repackaged Biological 
Products Based On Stability Testing'' of the guidance for biological 
products repackaged by outsourcing facilities for which the beyond use 
date (BUD) is established based on a stability program conducted in 
accordance with Appendix A.
    Section III.C of the guidance, ``Licensed Allergenic Extracts for 
Subcutaneous Immunotherapy,'' discusses the preparation of prescription 
sets (that is, licensed allergenic extracts that are mixed and diluted 
to provide subcutaneous

[[Page 22677]]

immunotherapy to an individual patient) by a physician, a State-
licensed pharmacy, a Federal facility, or an outsourcing facility. 
Another condition described in the guidance is that if the prescription 
set is prepared by an outsourcing facility, the label of the container 
from which the individual units of the prescription set are removed for 
administration (secondary packaging) includes the following information 
to facilitate adverse event reporting: https://www.fda.gov/medwatch and 
1-800-FDA-1088. Each prescription set prepared by an outsourcing 
facility is also accompanied by instructions for use.
    We estimate the burden of this information collection as follows:

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of    disclosures per   Total annual         Average burden per disclosure         Total hours
                                                 respondents      respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Radiopharmaceutical Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the compounder and                    10               25             250  .05 (3 minutes).........................            12.5
 prescriber and the notation on the
 prescription or order documenting the
 prescriber's determination of clinical
 difference.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Radiopharmaceutical Outsourcing and Repackaging Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each label                2                5              10  0.5 (30 minutes)........................               5
 on immediate containers, packages and/or
 outer containers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Repackaging Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each label                6               21             126  1.......................................             126
 on immediate containers, packages, and/or
 outer containers.
Biannual product reports identifying drug                   6                2              12  3.......................................              24
 products repackaged by the outsourcing
 facility during the previous 6-month period
 (Guidance Section III.A.).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Biologics Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing the label,               15                5              75  0.5 (30 minutes)........................            37.5
 container, packages, and/or outer containers
 for each mixed, diluted, or repackaged
 biological product.
Designing, testing, and producing each label                5              300           1,500  0.5 (30 minutes)........................             750
 on immediate containers, packages and/or
 outer containers for each licensed
 allergenic extract.
Maintaining records of testing performed in                 5               30             150  0.083 (5 minutes).......................            12.5
 accordance with Biologics Guidance Appendix
 A.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ...............           2,123  ........................................           967.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As defined in 44 U.S.C. 3502(13), the term ``recordkeeping 
requirement'' means a requirement imposed on respondents to maintain 
specified records, as well as a requirement to ``retain such records; 
notify third parties, the Federal Government, or the public of the 
existence of such records; disclose such records to third parties, the 
Federal Government, or the public; or report to third parties, the 
Federal Government, or the public regarding such records.'' For 
purposes of our analysis, therefore, we have characterized the burden 
associated with the time and effort expended on the information 
collection recommendations discussed in the respective guidance 
documents as recordkeeping activities. At the same time, our findings 
show that compliance with recordkeeping requirements applicable to 
compounded and repackaged drug products is standard practice in the 
compounding and selling of these drug products under States' pharmacy 
laws and other State laws governing recordkeeping by healthcare 
professionals and healthcare facilities. We have therefore excluded 
from our estimate recordkeeping practices discussed in the respective 
guidance documents we consider usual and customary. We invite comment 
on this assumption.
Radiopharmaceutical Compounding and Repackaging Guidance
    We estimate 10 compounders annually will consult a prescriber to 
determine whether a compounded radiopharmaceutical has a change that 
produces a clinical difference for an identified individual patient as 
compared to the comparable approved radiopharmaceutical. We estimate 
that those compounders will document this determination on 250 
prescriptions or orders for compounded radiopharmaceuticals. We assume 
consultation between the compounder and the prescriber and noting this 
determination on each prescription or order that does not already 
document this determination will take 3 minutes (0.05 hours) per 
prescription or order, for a total of approximately 12.5 hours.
Radiopharmaceutical Outsourcing and Repackaging Guidance
    We estimate a total of 2 outsourcing facilities annually will each 
design, test, and produce an average of 5 different labels for a total 
of 10 labels, as described in the guidance (including

[[Page 22678]]

directions for use). We assume that designing, testing, and producing 
each label will take 30 minutes (0.5 hours) for each repackaged 
radiopharmaceutical, for a total of 5 hours. We consider that the 
provision to include ``https://www.fda.gov/medwatch'' and ``1-800-FDA-
1088'' is not a collection of information as defined in 5 CFR 
1320.3(c)(2) and is therefore exempt from OMB review and approval under 
the PRA.
Repackaging Guidance
    Based on current data for outsourcing facilities, we estimate 6 
outsourcing facilities annually will submit an initial report 
identifying all drugs repackaged in the facility in the previous year. 
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 
repackaged may come in different strengths and can be reported in a 
single SPL response, we estimate that each facility will average 
approximately 6 products.
    Similarly, we estimate that 6 outsourcing facilities will submit an 
initial report identifying all drugs repackaged in the facility in the 
past year. Taking into account that a particular product that is 
repackaged may come in different strengths and can be reported in a 
single SPL response, we assume that each facility will average 6 
products. Our estimate is based on current product reporting data. We 
expect that each product report will consist of multiple SPL responses 
per facility and assume preparing and electronically submitting this 
information will take up to 2 hours for each initial SPL response.
    We also estimate 3 registered outsourcing facilities will submit a 
report twice each year (June and December) that identifies all drugs 
repackaged at the facility in the previous 6 months. We also estimate 
that an average of 3 facilities will prepare and submit 3 SPL responses 
and assume that preparing and submitting this information 
electronically will take 2 hours per response. If a product was not 
repackaged during a particular reporting period, outsourcing facilities 
do not need to send an SPL response for that product during that 
reporting period. We expect to receive no waiver requests from the 
electronic submission process for initial product reports and 
semiannual reports.
Biologics Guidance
    We estimate 15 outsourcing facilities annually who mix, dilute, or 
repackage biological products will each design, test, and produce 5 
different labels, for a total of 75 labels that include the information 
set forth in section III.B--``Mixing, Diluting, or Repackaging Licensed 
Biological Products'' of the guidance (including directions for use) as 
well as inclusion of storage instructions, handling instructions, or 
both. We assume that designing, testing, and producing each label will 
take 30 minutes (0.5 hours). We consider that the provision to include 
``https://www.fda.gov/medwatch'' and ``1-800-FDA-1088'' is not a 
collection of information as defined in 5 CFR 1320.3(c)(2) and is 
therefore exempt from OMB review and approval under the PRA.
    We estimate that annually a total of 5 outsourcing facilities who 
prepare prescription sets will each include on the labels, packages, 
and/or containers of approximately 300 prescription sets the 
information set forth in section III.C ``Licensed Allergenic Extracts 
for Subcutaneous Immunotherapy'' of the draft guidance (including 
directions for use), for a total of 1,500 disclosures. We assume the 
initial process of designing, testing, and producing labeling and 
attaching to each prescription set each label, package, and/or 
container will take approximately 30 minutes (0.5 hours), for a total 
of approximately 750 hours.
    Finally, we estimate that annually five outsourcing facilities who 
repackage biological products and establish a BUD in accordance with 
Appendix A--``Assigning a BUD for Repackaged Biological Products Based 
On Stability Testing'' will maintain 150 records of the testing, as 
described in Appendix A of the guidance. We assume maintaining the 
records will take 5 minutes per record, for a total of 12.5 hours.
    Our estimated burden for the information collection reflects 
program changes and adjustments. We are changing the scope of the 
information collection to include burden attendant to provisions found 
in the Agency guidance documents discussed in this notice and have 
adjusted our estimate to reflect a resulting increase of 955 hours and 
1,873 responses annually.

    Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08943 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P

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