2023-08277. Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 the information collection associated with statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps).

DATES:

Either electronic or written comments on the collection of information must be submitted by June 20, 2023.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 20, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received 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–2023–N–1168 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products.” 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.gpoinfo.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:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 240–994–7399, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Human Cells, Tissues, and Cellular and Tissue-Based Products—21 CFR Part 1271

OMB Control Number 0910–0543—Extension

This information collection helps support the implementation of statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps). Manufacturers of HCT/Ps regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264) are required to register and list HCT/Ps pursuant to part 1271 (21 CFR part 1271) whether or not the HCT/P enters into interstate commerce. Manufacturers of HCT/Ps regulated as drugs, devices and/or biological products under section 351 of the PHS Act (42 U.S.C. 262) and/or section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), are required to register and list HCT/Ps following the procedures in part 207 (21 CFR part 207) (if a drug and/or biological product) or part 807 (21 CFR part 807) (if a device). Information collection associated with the registration and listing requirements in parts 207 and 807 are currently approved in OMB control numbers 0910–0045 and 0910–0625, respectively.

Agency regulations in part 1271 set forth general provisions applicable to HCT/Ps in subpart A (§§ 1271.1 through 1271.20). Those HCT/Ps that are regulated solely under the authority of section 361 of the PHS Act are described in § 1271.10. Provisions in part 1271, subpart B (§§ 1271.21 through 1271.37), establish procedures for registration and listing including format and content elements along with scheduled timeframes for the submission of certain information and action by FDA. The regulations also provide for waivers from the electronic format requirement, amendments to establishment registration, and requesting information on registration and listing from FDA.

Registrants use Form FDA 3356, Establishment Registration and Listing for HCT/Ps, to submit HCT/P establishment registration and listing information to the Electronic Human Cell and Tissue Establishment Registration System (eHCTERs). Electronic submission of HCT/P establishment and product listing information is required under § 1271.22. However, a request for waiver of the electronic submission requirement may be submitted pursuant to § 1271.23. If the waiver request is granted, Form FDA 3356 (and accompanying instructions) may be downloaded to complete and submit by mail. The Tissue Establishment Registration page ( https://www.fda.gov/​vaccines-blood-biologics/​biologics-establishment-registration/​tissue-establishment-registration) provides access to eHCTERs, instructions for using eHCTERs, and other resource information that may be helpful to respondents.

Provisions in part 1271, subpart C (§§ 1271.45 through 1271.90), establish requirements for determining donor eligibility, including donor screening and testing, explaining these requirements are a component of current good tissue practice (CGTP) requirements set forth in part 1271, subpart D (§§ 1271.145 through 1271.320). The provisions in part 1271, subparts C and D, govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution.

The regulations in part 1271, subpart E and subpart F (§§ 1271.330 through 1271.440), establish additional requirements for establishments described in § 1271.10, including inspection and enforcement provisions, and recordkeeping requirements providing for the retention, notification to third parties, and disclosure of such records to FDA.

Description of Respondents: Respondents to this information collection are establishments that recover, process, store, label, package, or distribute any HCT/P that is regulated solely under section 361 of the PHS Act and regulations in part 1271 or perform donor screening or testing.

We estimate the burden of the information collection as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section; reporting activities	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours 2
1271.10(b)(1) and 1271.21(b); register and submit list of each HCT/P manufactured by existing establishments	2,374	1	2,374	0.5 (30 minutes)	1,187
1271.10(b)(1) and (2), 1271.21(a), and 1271.25(a) and (b); register and submit list of each HCT/P manufactured by new establishments	157	1	157	0.75 (45 minutes)	118
1271.10(b)(2), 1271.21(c)(2)(ii), and 1271.25(c); update list	566	1	566	0.5 (30 minutes)	283
1271.23; request electronic format waiver	1	1	1	1	1
1271.26; location/ownership amendments	346	1	346	0.25 (15 minutes)	87
1271.155(a); request exemption or alternative to any requirement	18	1.333	24	3	72
1271.350(a)(1) and (3); investigate and report adverse actions	15	14.266	214	1	214
1271.420(a); notify FDA (imports)	200	2.8	560	0.25 (15 minutes)	140
Total		23.399	4,242		2,102
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Rounded to the nearest whole number.

Based on current data from eHCTERS, we estimate there are 2,374 HCT/P current registrants and 157 new registrants, for a total of 2,531 respondents annually. Information collection provisions that include reporting activities are identified in table 1. The estimated burden for each of the individual reporting activities was calculated based on the annual number of submissions, averaged among respondents, and based on informal communications with industry.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR part 1271; establish and maintain records	Number of recordkeepers	Number of records per recordkeeper 2	Total annual records	Average burden per recordkeeping 2	Total hours 3
1271.47; Establishing SOPs	157	1	157	48	7,536
1271.47; Updating SOPs	2,374	1	2,374	24	56,976
1271 Subpart C & Subpart D: Establishing and maintaining records documenting methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution	2,531	3,311.36	8,381,049	0.26 (~15 minutes)	2,170,493
Total			8,383,580		2,235,005
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Decimals rounded to the nearest hundredth.
3  Rounded to the nearest whole number.

To calculate burden associated with the establishment and maintenance of operating procedures in accordance with applicable CGTP requirements, we assume twice the time is necessary for new establishments. Burden we attribute to recordkeeping activities associated with the remaining provisions in part 1271 is assumed to be distributed among the individual elements and averaged among respondents.

Table 3—Estimated Annual Third-Party Disclosure Burden ¹

21 CFR part 1271—human cells, tissues, and cellular and tissue-based products; activity	Number of respondents	Number of disclosures per respondent 2	Total annual disclosures	Average burden per disclosure 2	Total hours
Disclosing information as required under applicable good manufacturing practices/CGTP provisions	1,611	4,984.75	8,030,435	0.30 (~18 minutes)	2,389,226
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Decimals rounded to the nearest hundredth.

As part of the recordkeeping requirements, certain provisions in part 1271 require the disclosure of information to third parties, particularly as it pertains to the distribution of HCT/Ps. We estimate a proportion of the respondents to the information collection (1,611) will incur burden resulting from these disclosures and have therefore accounted for burden that may be attributable to these distinct activities.

Our estimated burden for the information collection reflects an overall reduction of 150,137 hours and 347,843 responses annually, which corresponds to a decrease in the number HCT/P establishments and a decrease in the number HCT/Ps distributed since our last evaluation.

Dated: April 14, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.