0543 Human cells tissue SSA 2020 EXT

UNITED STATES FOOD AND DRUG ADMINISTRATION
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps):
Establishment Registration and Listing;
Eligibility Determination for Donors;
and Current Good Tissue Practice (CGTP)
OMB Control No. 0910-0543
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations
related to human cells, tissues, and cellular and tissue-based products (HCT/Ps). Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 361 of the Public Health Service
Act (the PHS Act) (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent
the introduction, transmission, or spread of communicable diseases between the States or
possessions or from foreign countries into the States. As derivatives of the human body, all
HCT/Ps pose some risk of carrying pathogens that could potentially infect recipients or handlers.
Accordingly, our regulations in 21 CFR part 1271 govern HCT/Ps electronic establishment
registration and listing using an electronic system, eligibility determination for donors, and
current good tissue practice (CGTP). The regulations are necessary to prevent the introduction,
transmission, or spread of communicable diseases. We therefore request extension of OMB
approval of the information collection provisions found in 21 CFR part 1271, as well as the
Electronic Human Cell and Tissue Establishment Registration System (eHCTERS), as discussed
in this supporting statement.
2. Purpose and Use of the Information Collection
We use the information received from establishments complying with registration and listing
requirements to regulate the industries involved with the recovery, screening, testing, processing,
storage, and distribution of HCT/Ps. The information allows FDA to efficiently and effectively
handle emerging public health concerns related to HCT/Ps. The information also aids FDA to
monitor the industry, to distribute educational materials, and to inform the industry about FDA
requirements, guidances, and policies, and to identify entities that may be subject to FDA
regulation.
Documentation of donor eligibility determination provides to the user that all of the donor’s
medical history and social behavior were reviewed for high risk for or clinical evidence of
communicable diseases, and that all of the required testing was completed. Each distributed
HCT/P must have the following accompanying documentation: (1) a distinct identification code;
(2) a statement, based on the screening and testing results, that the donor is determined to be
eligible or ineligible; and (3) a summary of the records used to determine eligibility. The
summary of records must contain: (1) a statement that the testing was performed by a Clinical
Laboratory Improvement Amendments certified laboratory or by a laboratory that has met

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equivalent requirements as determined by the Centers for Medicare and Medicaid Services; (2) a
listing and interpretation of the results of all communicable disease tests performed; (3) the name
and address of the establishment determining the eligibility of the donor; and (4) in the case of an
HCT/P from a donor determined to be ineligible based on screening and released for use under §
1271.65(b), a statement noting the reason for the ineligible determination.
Other reporting and recordkeeping requirements in 21 CFR part 1271 are designed to fully
disclose the screening and testing results to the user when using products from donors who are
determined to be ineligible or whose eligibility has not yet been determined in an urgent medical
need. The distributing establishment is also to document that the HCT/P establishment notified
the physician that the screening and testing are not completed. HCT/P establishments are
required to maintain records for a minimum of 10 years. Certain HCT/Ps have long storage
periods and advances in medical diagnosis and therapy also have created opportunities for
disease prevention or treatment many years after a recipient’s exposure to a donor later
determined to be at risk for communicable disease agents or diseases.
The CGTP information collection provisions provide: (1) additional measures for preventing the
introduction, transmission, or spread of communicable disease; (2) step-by step consistency in
the manufacturing of the product; (3) necessary information to FDA for the purpose of protecting
public health and safety; (4) accountability in the manufacturing of cellular and tissue-based
products; and (5) information facilitating the tracking of a product back to its original source or
to a consignee or final disposition.
Without this collection of information, FDA could not monitor HCT/Ps procedures and could not
fulfill its statutory responsibility to prevent the introduction, transmission, or spread of
communicable diseases between the States or possessions or from foreign countries into the
States.
3. Use of Improved Information Technology and Burden Reduction
Electronic submission of HCT/P establishment and product listing information is now required
under §1271.22, unless waived in certain circumstances. HCT/P establishments that must
register and list electronically under 21 CFR Part 1271 should use eHCTERS (available at:
https://www.accessdata.fda.gov/scripts/cber/CFApps/Login/Index.cfm) to meet the requirement
for electronic submission of establishment registration and product listing. Establishments may
request a waiver from the electronic submission requirement as described in §1271.23. With
regard to recordkeeping, companies are free to use whatever forms of information technology
may best assist them in retaining the appropriate records and making them available to
regulatory officials. Our regulation at 21 CFR 1271.270(c) provides that establishments may
maintain records electronically.
4. Efforts to Identify Duplication and use of Similar Information
We are unaware of duplicative information collection. Manufacturers of drug or device products
that incorporate human cells or tissues register using the FDA eHCTERS electronic system. To
avoid duplication, 21 CFR parts 210, 211, and 820 state that in the event of a conflict between

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applicable regulations in parts 210, 211, and 820 and the regulations in part 1271, the regulation
specifically applicable to the product in question must supersede the more general.
5. Impact on Small Businesses or Other Small Entities
The regulatory requirements apply to all respondents. The recordkeeping requirements are the
minimum requirements for CGTP. To assist small businesses, FDA’s Center for Biologics
Evaluation and Research (CBER) provides industry guidance on its website and has established
small business assistance contacts within its Office of Communication, Outreach, and
Development (OCOD), Division of Manufacturer’s Assistance and Training (DMAT),
Manufacturers Assistance and Technical Training Branch (MATT) (email:
[email protected]).
6. Consequences of Collecting the Information Less Frequency
Information collection is consistent with statutory requirements. Less frequent collection of
information would not provide FDA the information needed to prevent the transmission of
communicable disease by HCT/Ps through monitoring, and communication with the cell and
tissue industry. The documentation of donor eligibility, the summary of records, and the
information provided to physicians on the donor’s eligibility when a product is used in an urgent
medical need is the minimum necessary to keep the industry informed of the eligibility of each
and every donor of HCT/Ps. The reporting and recordkeeping requirements of CGTP are
designed to impose minimum burden on industry while preventing the introduction,
transmission, or spread of communicable disease through the use of HCT/Ps. There are no
technical or legal obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The reporting regulations under 21 CFR part 1271, subparts C and D, require respondents to
provide information more often than quarterly, i.e., for each individual HCT/P. This
information includes an identification code number, which protects patient/donor confidential
information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of December 5, 2019 (84 FR 66673). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.

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10. Assurance of Confidentiality provided to respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate
handling of information collected. The information collection captures personally identifiable
information (PII) or information of a personal nature including name, mailing address, email
address, and telephone number. PII is collected in the context of the individual’s professional
capacity. We have determined, however, that the PII collected is not subject to the Privacy Act
of 1974 and the particular notice and other requirements of the Act do not apply. Specifically,
FDA does not use name or any other personal identifier to routinely retrieve records from the
information collected. Inspectors may copy records as part of the inspection of a tissue
establishment. Establishment records describing manufacturing procedures and CGTP records
that we may copy or take possession of during an inspection often contain trade secret and
confidential commercial information. Confidential commercial information is protected from
disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C.
552(a) and (b)); by Section 301(j) of the FD&C Act; and, by part 20 of our regulations (21 CFR
part 20).
11. Justification for Sensitive Questions
Questions of a sensitive nature, such as sexual behavior and other matters that are
commonly considered private must be asked by the HCT/P establishments as part of the
donor medical history evaluation. The answers to these questions help determine the
eligibility of a donor. Donors that do not meet certain criteria would be determined
ineligible to donate. This information is necessary to prevent the transmission of relevant
communicable diseases and to protect the public health. Such information may be
reviewed by FDA during an inspection.
12. Annualized Burden Estimate
12a. Annualized Burden Estimate
Table 1.--Estimated Annual Reporting Burden1
21 CFR Part 1271; Human
Cells, Tissues, and Cellular and
Tissue-Based Products
1271.10(b)(1) and 1271.21(b)2
1271.10(b)(1) and (2),
1271.21(a), and 1271.25(a) and
(b)2
1271.10(b)(2), 1271.21(c)(2)(ii)
and 1271.25(c)2
1271.23
1271.262
1271.155(a)
1271.350(a)(1) and (3)
1271.420(a)

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

2,736

1

2,736

193

1

193

1,062

1

1,062

1
358

1
1

1
358

15

4.27

13
200

14.46
2.8

Average
Burden per
Response

Total
Hours3

0.5
(30 minutes)
0.75
(45 minutes)

1,368

531

64

0.5
(30 minutes)
1
0.25
(15 minutes)
3

192

188
560

1
0.25

188
140

145

1
90

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

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours3

(15 minutes)
5,162
2,655
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Using eHCTERS.
3
Rounded to the nearest whole number.
Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Part 1271; Human
Cells, Tissues, and Cellular
and Tissue-Based Products

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeeping

New SOPs2
SOP Update2
1271.47(d)
1271.50(a)
1271.55(d)(1)
1271.55(d)(2)
1271.55(d)(4)
1271.60(d)(3) and (4)
1271.65(b)(3)(iii)
1271.155(f)

193
2,736
1,368
2,736
2,736
2,736
2,736
821

1
1
1
39.846
39.846
1
1
1

193
2,736
1,368
109,019
109,019
2,736
2,736
821

48
24
1
5
1
1
120
2

9,264
65,664
1,368
545,095
109,019
2,736
328,320
1,642

15

4.27

64

16

1271.160(b)(3) and (6)
1271.160(d)
1271.190(d)(2)
1271.195(d)

2,109
2,109
2,109
2,109

12
12
12
12

25,308
25,308
25,308
25,308

0.25
(15 minutes)
1
1
1
1

1271.200(e)
1271.210(d)
1271.230(a)
1271.230(c)
1271.260(d)

2,109
2,109
2,109
2,109
2,109

12
12
12
1
12

25,308
25,308
25,308
2,109
25,308

1271.260(e)

2,109

365

769,785

1271.265(c)(1)

2,109

1,163.781

2,454,415

1271.265(c)(3)
1271.265(e)

1,055
2,109

1
1,163.781

1,055
2,454,415

1271.270(a)

2,109

1,163.781

2,454,415

1271.270(e)

2,189

2

4,378

1271.290(d) and (e)

2,109

49.037

103,419

1271.320(b)

1,687

5

1
1
1
1
0.25
(15 minutes)
0.083
(5 minutes)
0.083
(5 minutes)
1
0.083
(5 minutes)
0.25
(15 minutes)
0.5
(30 minutes)
0.25
(15 minutes)
1

Total
Hours3

25,308
25,308
25,308
25,308
25,308
25,308
25,308
2,109
6,327
63,892
203,716
1,055
203,716
613,604
2,189
25,855

8,435
8,435
8,683,582
2,371,178
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

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2

Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b),
1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e).
3
Rounded to the nearest whole number.
Table 3.--Estimated Annual Third-Party Disclosure Burden1
21 CFR Part 1271; Human
Cells, Tissues, and Cellular
and Tissue-Based Products

No. of
Respondents

No. of
Disclosures per
Respondent

Total Annual
Disclosures

1271.55(a)

1,632

1,589.715

2,594,415

1271.60(c) and (d)(2)

1,611

355.06

572,000

1271.290(c)

2,109

1,163.781

2,454,415

1271.290(f)
1271.370(b) and (c)

2,109
2,109

1
1,163.781

2,109
2,454,415

Average
Burden per
Disclosure
0.5
(30 minutes)
0.5
(30 minutes)
0.083
(5 minutes)
1
0.25
(15 minutes)

Total
Hours
1,297,208
286,000
203,716
2,109
613,604

Total
9,570
8,077,354
2,402,637
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Rounded to the nearest whole number.
1

12b. Annualized Cost Estimate
The estimated annual cost to respondents is $234,354,056.00.
Activity

No. of Hours

Cost per Hour

Total Cost

Reporting

2,655

$58

$153,990

Recordkeeping

2,371,178

$40

$94,847,120

Disclosure

2,402,637

$58

$139,352,946

Total

$234,354,056

The reporting/disclosure cost estimate is based on an average pay rate of $58 an hour. The
average is based on the salaries of a medical director ($85/hour), a mid-level supervisor
($54/hour, responsible for completing and submitting the registration and/or listing
information; creating, reviewing, or updating SOPs; or on other reporting responsibilities),
and a medical technician ($36/hour). The recordkeeping cost estimate is based on an
average pay rate of $44/hour of a mid-level professional and a medical technician who are
involved with the documentation and maintenance of records. The estimated average hourly
pay rate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this collection
of information.

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14. Cost to the Federal Government
The estimated annualized cost to FDA is $5,195,140.00.
Activity
Registration and Listing
Exemption or Alternative
Request
Establishment (non-reproductive)
Inspection
Establishment (reproductive)
Inspection
AER triage/review

Total Cost

Number of
Responses
4,349
64

Hours per
Response
3
3

Cost per
Hour
$44
$71

1,055

69

$61

$4,440,495

157

17

$61

$162,809

188

0.5 (30 mins)

$44

$4,136

Total

$574,068
$13,632

$5,195,140

The estimated cost is based on 2 FTEs (GS-7/5 and GS-13/5), with an average pay rate of $44
an hour, who process and review the registration form, input the data, and maintain the
database; and who triage and review AERs. There are approximately 2,109 non-reproductive
HCT/P establishments that would be inspected on a biennial basis (2,109/2 = 1,055) by a
FDA Inspector at an average grade of GS-13/5, with an average pay rate of $61 an hour. The
estimated time includes inspection, reviewing records and writing up a report. There are
approximately 627 (2,736 – 2,109 = 627) reproductive HCT/P establishments that would be
inspected for compliance with the donor eligibility requirements every 4 years (627/4 =157)
per year). This cost is also based on FDA regulatory review staff who process and review the
requests for exemptions or alternatives, with an average pay rate of $71 an hour. The salary
estimates include benefits but no overhead costs.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. We have increased the number of respondents
based on the number of registered establishments. We have also incorporated burden from
electronic registration requirements now mandatory as a result of final rule RIN 0910-AA49.
This results in an overall increase in annual responses by 2,584,285 but reduces the annual hours
by 4,559,578.
16. Plans for Tabulation and Publication and Project Time Schedule
The information collected will not be published or tabulated. However, the public may review
tissue establishment registration information for registered, inactive, and pre-registered
establishments by using the eHCTERS Public Query application available at:
https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/Index.cfm.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not seeking approval to exempt the display of the expiration date of the OMB Approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.