[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Notices]
[Pages 11545-11549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0101]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based 
Products: Establishment Registration and Listing; Form FDA 3356; 
Eligibility Determination for Donors; and Current Good Tissue Practice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 
requirements for FDA regulations related to human cells, tissues, and 
cellular and tissue-based products (HCT[sol]Ps) involving establishment 
registration and listing using Form FDA 3356; eligibility determination 
for donors; and current good tissue practice (CGTP).

DATES:  Submit written or electronic comments on the collection of 
information by May 10, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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)

[[Page 11546]]

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: 
Establishment Registration and Listing; Form FDA 3356; Eligibility 
Determination for Donors; and Current Good Tissue Practice--(OMB 
Control Number 0910-0543)--Extension

    Under 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[sol]Ps pose 
some risk of carrying pathogens that could potentially infect 
recipients or handlers. FDA has issued regulations related to 
HCT[sol]Ps involving establishment registration and listing using Form 
FDA 3356, eligibility determination for donors, and CGTP.

A. Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic 
and foreign establishments that recover, process, store, label, 
package, or distribute an HCT[sol]P described in Sec.  1271.10(a), or 
that perform screening or testing of the cell or tissue donor to 
register with FDA (Sec.  1271.10(b)(1)) and submit a list of each 
HCT[sol]P manufactured (Sec.  1271.10(b)). Section 1271.21(a) requires 
an establishment to follow certain procedures for initial registration 
and listing of HCT[sol]Ps, and Sec.  1271.25(a) and (b) identifies the 
required initial registration and HCT[sol]P listing information. 
Section 1271.21(b), in brief, requires an annual update of the 
establishment registration. Section 1271.21(c)(ii) requires 
establishments to submit HCT[sol]P listing updates when an HCT[sol]P is 
changed as described in Sec.  1271.25(c). Section 1271.25(c) identifies 
the required HCT[sol]P listing update information. Section 1271.26 
requires establishments to submit an amendment if ownership or location 
of the establishment changes. FDA requires the use of a registration 
and listing form (Form FDA 3356: Establishment Registration and Listing 
for Human Cells, Tissues, and Cellular and Tissue-Based Products 
(HCT[sol]Ps)) to submit the required information (Sec. Sec.  1271.10, 
1271.21, 1271.25, and 1271.26). To further facilitate the ease and 
speed of submissions, electronic submission is accepted (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm).

B. Eligibility Determination for Donors

    In brief, FDA requires certain HCT[sol]P establishments described 
in Sec.  1271.1(b) to determine donor eligibility based on donor 
screening and testing for relevant communicable diseases agents and 
diseases, except as provided under Sec.  1271.90. The documented 
determination of a donor's eligibility is made by a responsible person 
defined in Sec.  1271.3(t) and is based on the results of required 
donor screening, which includes a donor medical history interview 
(defined in Sec.  1271.3(n)) and testing (Sec.  1271.50(a)). Certain 
records must accompany an HCT[sol]P once the donor-eligibility 
determination has been made (Sec.  1271.55(a)). This requirement 
applies both to an HCT[sol]P from a donor who is determined to be 
eligible as well as to an HCT[sol]P from a donor who is determined to 
be ineligible or where the donor-eligibility determination is not 
complete if there is a documented urgent medical need (Sec.  1271.60). 
Once the donor-eligibility determination has been made, the HCT[sol]P 
must be accompanied by a summary of records used to make the donor-
eligibility determination (Sec.  1271.55(b)) and a statement whether, 
based on the results of the screening and testing, the donor is 
determined to be eligible or ineligible (Sec.  1271.55(a)(2)).
    Records used in determining the eligibility of a donor, i.e., 
results and interpretations of testing for relevant communicable 
disease agents, the donor-eligibility determination, the name and 
address of the testing laboratory or laboratories, and the name of the 
responsible person (defined in Sec.  1271.3(t)) who made the donor-
eligibility determination and the date of the determination, must be 
maintained (Sec.  1271.55(d)(1)). If any information on the donor is 
not in English, the original record must be retained and translated to 
English and accompanied by a statement of authenticity from the 
translator (Sec.  1271.55(d)(2)). HCT[sol]P establishments must retain 
the records pertaining to HCT[sol]Ps at least 10 years after the date 
of administration, distribution, disposition, or expiration, whichever 
is latest (Sec.  1271.55(d)(4)).
    When a product is shipped in quarantine as defined in Sec.  
1271.3(q), before completion of screening and testing, the HCT[sol]P 
must be accompanied by records identifying the donor; stating that the 
donor-eligibility determination has not been completed; and stating 
that the product must not be used until the donor-eligibility 
determination has been completed (Sec.  1271.60(c)). When an HCT[sol]P 
is used in cases of documented urgent medical need, the results of any 
completed donor screening and testing, and a list of any required 
screening and testing not yet completed also must accompany the 
HCT[sol]P (Sec.  1271.60(d)(2)). When an HCT[sol]P is used in cases of 
urgent medical need or from a donor who has been determined to be 
ineligible (as permitted under Sec.  1271.65), documentation by the 
HCT[sol]P establishment is required showing that the recipient's 
physician received notification that the testing and screening were not 
complete (in cases of urgent medical need), and upon the completion of 
the donor-eligibility determination, of the results of the 
determination (Sec.  1271.60(d)(3) and (d)(4) and Sec.  1271.65(b)(3)).
    An HCT[sol]P establishment is also required to establish and 
maintain procedures for all steps that are performed in determining 
eligibility (Sec.  1271.47(a)), including the use of a product from a 
donor testing reactive for cytomegalovirus (Sec.  1271.85(b)(2)). The 
HCT[sol]P establishment must record any departure from the procedures 
(Sec.  1271.47(d)).

C. Current Good Tissue Practice (CGTP)

    FDA requires certain HCT[sol]P establishments to follow CGTP

[[Page 11547]]

(Sec.  1271.1(b)). Section 1271.155(a) permits the submission of a 
request for FDA approval of an exemption from or alternative to any 
requirement in subpart C or D of part 1271. Section 1271.290(c) 
requires such establishments to affix a distinct identification code to 
each HCT[sol]P that it manufactures that relates the HCT[sol]P to the 
donor and to all records pertaining to the HCT[sol]P. Whenever an 
establishment distributes an HCT[sol]P to a consignee, Sec.  
1271.290(f) requires the establishment to inform the consignee, in 
writing, of the product tracking requirements and the methods the 
establishment uses to fulfill the requirements. Non-reproductive 
HCT[sol]P establishments described in Sec.  1271.10 are required under 
Sec. Sec.  1271.350(a)(1) and (a)(3) to investigate and report to FDA 
adverse reactions (defined in Sec.  1271.3(y)) using Form FDA-3500A 
(Sec.  1271.350(a)(2)). Form FDA-3500A is approved under OMB Control 
No. 0910-0291. Section 1271.370(b) and (c) requires establishments to 
include specific information either on the HCT[sol]P label or with the 
HCT[sol]P.
    The standard operating procedures (SOP) provisions under part 1271 
include the following: (1) Section 1271.160(b)(2) (receiving, 
investigation, evaluating, and documenting information relating to core 
CGTP requirements, including complaints, and for sharing information 
with consignees and other establishments); (2) Sec.  1271.180(a) (to 
meet core CGTP requirements for all steps performed in the manufacture 
of HCT[sol]Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and 
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and 
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of 
equipment); (6) Sec.  1271.230(a) and (c) (validation of changes to a 
process); (7) Sec.  1271.250(a) (controls for labeling HCT[sol]Ps); (8) 
Sec.  1271.265(e) (receipt, predistribution shipment, availability for 
distribution, and packaging and shipping of HCT[sol]Ps); (9) Sec.  
1271.265(f) (suitable for return to inventory); (10) Sec.  1271.270(b) 
(records management system); (11) Sec.  1271.290(b)(1) (system of 
HCT[sol]P tracking); and (12) Sec.  1271.320(a) (review, evaluation, 
and documentation of complaints (as defined in Sec.  1271.3(aa))).
    Section 1271.155(f) requires an establishment operating under the 
terms of an exemption or alternative to maintain documentation of the 
terms and date of FDA approval. Section 1271.160(b)(3) requires 
documentation of appropriate corrective actions taken as a result of an 
audit of the quality program. Section 1271.160(b)(6) requires 
documentation of HCT[sol]P deviations. Section 1271.160(d) requires 
documentation of computer validation or verification activities and 
results when computers are used to comply with the core CGTP 
requirements for its intended use. Section 1271.190(d)(2) requires 
documentation of all facility cleaning and sanitation activities 
performed to prevent contamination of HCT[sol]Ps. Section 1271.195(d) 
requires documentation of environmental control and monitoring 
activities. Section 1271.200(e) requires documentation of equipment 
maintenance, cleaning, sanitizing, calibration, and other activities. 
Section 1271.210(d) requires documentation of the receipt, 
verification, and use of each supply or reagent. Section 1271.230(a) 
requires documentation of validation activities when the results of a 
process cannot be fully verified by subsequent inspection and tests. 
Section 1271.230(c) requires documentation of the review and evaluation 
of a process and revalidation of the process, if necessary, when any 
changes to a validated process occur. Section 1271.260(d) and (e) 
requires documentation of any corrective action taken when proper 
storage conditions are not met and documentation of storage 
temperatures for HCT[sol]Ps. Section 1271.265(c)(1) requires 
documentation that release criteria have been met before distribution 
of an HCT[sol]P. Section 1271.265(c)(3) requires documentation of any 
departure from a procedure at the time of its occurrence. Section 
1271.265(e) requires documentation of the receipt, predistribution 
shipment, distribution, and packaging and shipping of HCT[sol]Ps. 
Section 1271.270(a) requires documentation of each step in 
manufacturing required in part 1271, subparts C and D. Section 
1271.270(e) requires documentation of the name and address, and a list 
of responsibilities of any establishment that performs a manufacturing 
step for an establishment. Sections 1271.290(d) and (e) require 
documentation of a method for recording the distinct identification 
code and type of each HCT[sol]P distributed to a consignee to enable 
tracking from the consignee to the donor and to enable tracking from 
the donor to the consignee or final disposition. Section 1271.320(b) 
requires an establishment to maintain a record of each complaint that 
it receives, that contains relevant information for proper review and 
evaluation.
    Respondents to this information collection are establishments that 
recover, process, store, label, package, or distribute any HCT[sol]P, 
or perform donor screening or testing. The estimates provided below are 
based on the most recent available information from FDA's database 
system and trade organizations. The hours per response and hours per 
record are based on data provided by the Eastern Research Group, or FDA 
experience with similar recordkeeping or reporting requirements.
    There are an estimated 2,281 HCT[sol]P establishments (conventional 
tissue, eye tissue, peripheral blood stem cell, stem cell products from 
cord blood, reproductive tissue, and sperm banks), including 692 
manufacturers of HCT[sol]P products regulated under the Federal Food, 
Drug, and Cosmetics Act and section 351 of the PHS Act (42 U.S.C. 262), 
that have registered and listed with FDA. In addition, we estimate that 
251 new establishments have registered with FDA (Sec.  1271.10(b)(1) 
and (b)(2) and Sec.  1271.25(a) and (b)). There are an estimated 2,230 
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and 
1271.25(c)) and 565 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,167,396 HCT[sol]Ps 
(which include conventional tissues, eye tissues, hematopoetic stem 
cells/progenitor cells, and reproductive cells and tissues) and an 
estimated total of 2,026,024 non-reproductive cells and tissues (total 
HCT[sol]Ps minus reproductive cells and tissues) are distributed per 
year by an estimated 1,589 establishments (2,281 - 692 = 1,589 
establishments with approved applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375 
establishments shipped an estimated 286,000 HCT[sol]Ps under 
quarantine, and that an estimated 18 establishments requested an 
exemption from or alternative to any requirement under part 1271, 
subpart C or D, specifically under Sec.  1271.155(a).
    Under Sec.  1271.290(c) and Sec.  1271.370(b) and (c), an estimated 
1,694 non-reproductive HCT[sol]P establishments label each of their 
2,026,024 HCT[sol]Ps with certain information. These establishments are 
also required to inform their consignees in writing of the requirements 
for tracking and of their established tracking system under Sec.  
1271.290(f).
    FDA estimates 38 HCT[sol]P establishments submitted 76 adverse 
reaction reports involving a communicable disease (Sec.  
1271.350(a)(1)).
    FDA estimates that 251 new establishments will create SOPs, and 
that 2,281 establishments will review and revise existing SOPs 
annually.
    FDA estimates that 1,141 HCT[sol]P establishments (2,281 x 50% = 
1,141)

[[Page 11548]]

and 847 non-reproductive HCT[sol]P establishments (1,694 x 50% = 847) 
record and justify a departure from the procedures (Sec. Sec.  
1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT[sol]P establishments are required to 
have a documented medical history interview about the donor's medical 
history and relevant social behavior as part of the donor's relevant 
medical records for each of the estimated total of 91,240 donors (which 
include conventional tissue donors, eye tissue donors, peripheral and 
cord blood stem cell donors, and reproductive cell and tissue donors), 
and the estimated total of 86,394 non-reproductive cells and tissue 
donors (total donors minus reproductive cell and tissue donors).
    FDA estimates that 684 HCT[sol]P establishments (2,281 x 30% = 684) 
document an urgent medical need for an HCT[sol]P and notify the 
physician using the HCT[sol]P (Sec.  1271.60(d)(3) and (d)(4) and Sec.  
1271.65(b)(3)(iii)).
    FDA also estimates that 1,824 HCT[sol]P establishments (2,281 x 80% 
= 1,824) have to maintain records for an average of 2 contract 
establishments that perform a manufacturing process step for them 
(Sec.  1271.270(e)) and 1,141 HCT[sol]P establishments maintain an 
average of 5 complaint records annually (Sec.  1271.320(b)).
    In some cases, the estimated burden may appear to be lower or 
higher than the burden experienced by individual establishments. The 
estimated burden in these charts is an estimated average burden, taking 
into account the range of impact each regulation may have.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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1271.10(b)(1) and 1271.21(b)\2\                                     2,281                     1              2,281               .5                1,141
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1271.10(b)(1) and (b)(2), 1271.21(a), and 1271.25(a)                  251                     1                251               .75                 188
 and (b)\2\
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1271.10(b)(2), 1271.21(c)(2)(ii), and 1271.25(c)\2\                 2,230                     1              2,230               .5                1,115
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1271.26\2\                                                            565                     1                565               .25                 141
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1271.55(a)                                                          1,589                 1,364          2,167,396               .5            1,083,698
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1271.60(c) and (d)(2)                                               1,375                   208            286,000               .5              143,000
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1271.155(a)                                                            18                     1                 18              3                     54
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1271.290(c)                                                         1,694                 1,196          2,026,024               .083            168,835
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1271.290(f)                                                         1,694                     1              1,694              1                  1,694
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1271.350(a)(1) and (a)(3)                                              38                     2                 76              1                     76
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1271.370(b) and (c)                                                 1,694                 1,196          2,026,024               .25             506,506
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Total                                                                                                                                          1,906,448
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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New SOPs\2\                                                           251                     1                251             48                 12,048
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SOP Update\2\                                                       2,281                     1              2,281             24                 54,744
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1271.47(d)                                                          1,141                     1              1,141              1                  1,141
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1271.50(a)                                                          2,281                    40             91,240              5                456,200
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1271.55(d)(1)                                                       2,281                    40             91,240              1                 91,240
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1271.55(d)(2)                                                       2,281                     1              2,281              1                  2,281
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1271.55(d)(4)                                                       2,281                     1              2,281            120                273,720
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1271.60(d)(3) and (d)(4), and 1271.65(b)(3)(iii)                      684                     1                684              2                  1,368
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1271.155(f)                                                            18                     1                 18               .25                   5
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[[Page 11549]]

 
1271.160(b)(3) and (b)(6)                                           1,694                    12             20,328              1                 20,328
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1271.160(d)                                                         1,694                    12             20,328              1                 20,328
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1271.190(d)(2)                                                      1,694                    12             20,328              1                 20,328
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1271.195(d)                                                         1,694                    12             20,328              1                 20,328
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1271.200(e)                                                         1,694                    12             20,328              1                 20,328
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1271.210(d)                                                         1,694                    12             20,328              1                 20,328
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1271.230(a)                                                         1,694                    12             20,328              1                 20,328
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1271.230(c)                                                         1,694                     1              1,694              1                  1,694
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1271.260(d)                                                         1,694                    12             20,328               .25               5,082
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1271.260(e)                                                         1,694                   365            618,310               .083             51,526
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1271.265(c)(1)                                                      1,694                 1,196          2,026,024               .083            168,835
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1271.265(c)(3)                                                        847                     1                847              1                    847
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1271.265(e)                                                         1,694                 1,196          2,026,024               .083            168,835
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.270(a)                                                         1,694                 1,196          2,026,024               .25             506,506
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.270(e)                                                         1,824                     2              3,648               .5                1,824
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1271.290(d) and (e)                                                 1,694                    51             86,394               .25              21,599
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1271.320(b)                                                         1,141                     5              5,705              1                  5,705
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Total                                                                                                                                          1,967,496
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\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).


    Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5229 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S