Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21027 

H. Humphrey Building, whether 

personal or for the purpose of 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for the purpose 

of presentation. 

Individuals requiring sign language 

interpretation or other special 

accommodation must contact the DFO 

via the contact information specified in 

the FOR FUTHER INFORMATION CONTACT

section of this notice by the date listed 

in the DATES section of this notice. 

Authority: (Section 1868 of the Social 

Security Act (42 U.S.C. 1395ee) and section 

10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, 

section 10(a)).) 

Dated: April 10, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–7382 Filed 4–26–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0018] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Cells, 

Tissues, and Cellular and TissueBased Products: Establishment 

Registration and Listing; Form Food 

and Drug Administration 3356; 

Eligibility Determination for Donors; 

and Current Good Tissue Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 29, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the OMB control number 

0910–0543. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products: Establishment 

Registration and Listing; Form Food 

and Drug Administration 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 human cells, 

tissues, and cellular and tissue-based 

products (HCT/Ps) pose some risk of 

carrying pathogens that could 

potentially infect recipients or handlers. 

FDA has issued regulations related to 

HCT/Ps involving establishment 

registration and listing using Form FDA 

3356; eligibility determination for 

donors; and current good tissue practice 

(CGTP). 

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 any 

HCT/Ps, or that perform screening or 

testing of the cell or tissue donor to 

register with FDA (§ 1271.10(b)(1)) and 

submit a list of each HCT/P 

manufactured (§ 1271.10(b)(2)).Section 

1271.21(a) requires the initial 

establishment registration, and 

§ 1271.25(a) and (b) identifies the 

required initial registration and HCT/P 

listing information. Section 1271.21(b) 

requires an annual update of the 

establishment registration. Section 

1271.21(c)(ii) requires establishments to 

submit HCT/P listing updates when an 

HCT/P is changed as described in 

§ 1271.25(c). Section 1271.25(c) 

identifies the required HCT/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 to submit 

the required information (§§ 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/cber/ 

tissue/tisreg.htm). 

Eligibility Determination for Donors 

FDA requires HCT/P establishments 

described in § 1271.1(b) to screen and 

test the donors of cells and tissue used 

in those products for risk factors for and 

clinical evidence of relevant 

communicable diseases agents and 

diseases. The documented 

determination of a donor’s eligibility is 

made by a responsible person and is 

based on the results of required donor 

screening, which includes a donor 

medical history interview (defined in 

§ 1271.3(n)), and testing (§ 1271.50(a)). 

HCT/P establishments are permitted to 

ship an HCT/P only if it is accompanied 

by documentation of the donoreligibility determination (§ 1271.55(a)). 

This requirement applies to an HCT/P 

from a donor determined to be eligible 

as well as to a product from a donor 

who is determined to be ineligible and 

made available for use under certain 

provisions. The accompanying 

documentation must contain a summary 

of records used to determine donor 

eligibility, and a statement whether, 

based on the results of the screening and 

testing of the donor, that the donor is 

determined to be eligible or ineligible. 

Records used in determining the 

eligibility of a donor, i.e., results and 

interpretations of screening and testing, 

the donor eligibility determination, the 

name and address of the testing 

laboratory or laboratories, and the name 

of the responsible person who made the 

determination and the date, must be 

maintained (§ 1271.55(d)(1)). If any 

information on the donor is not in 

English, the HCT/P establishment must 

retain the original record and the 

statement of authenticity from the 

translator (§ 1271.55(d)(2)). HCT/P 

establishments must retain the records 

pertaining to HCT/Ps at least 10 years 

after the date of administration, 

distribution, disposition, or expiration, 

whichever is latest (§ 1271.55(d)(4)). 

When a product is shipped in 

quarantine, before completion of 

screening and testing, the HCT/P 

establishment must provide the donor 

identification, a statement that the 

donor-eligibility determination is not 

completed and that the product is not to 


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21028 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

be used until eligibility determination is 

completed (§ 1271.60(c)). With the use 

of a product from an incompletely 

tested donor, the results of any 

completed donor screening and testing, 

and a list of any required screening and 

testing not yet completed must 

accompany the HCT/P (§ 1271.60(d)(2)). 

When using an HCT/P from an 

ineligible donor, documentation by the 

HCT/P establishment is required 

showing that the recipient’s physician 

received notification of the screening 

and testing results (§§ 1271.60(d)(3) and 

1271.65(b)(3)). An HCT/P establishment 

is also required to establish and 

maintain procedures for all steps that 

are performed in determining eligibility 

(§ 1271.47(a)), including the use of a 

product from a donor testing positive for 

cytomegalovirus (§ 1271.85(b)(2)). The 

HCT/P establishment must record any 

departure from the procedures 

(§ 1271.47(d)). 

Current Good Tissue Practice 

FDA requires certain HCT/P 

establishments to follow CGTPs. Section 

1271.155(a) permits the submission of a 

request for FDA approval of an 

exemption or an alternative from any 

requirement in subpart C or D of part 

1271. Section 1271.290(c) requires the 

establishment to affix a distinct 

identification code to each HCT/P 

relating the HCT/P to the donor and all 

records pertaining to the HCT/P. 

Whenever an establishment initially 

distributes an HCT/P to a consignee, 

§ 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. Nonreproductive HCT/P establishments 

described in § 1271.10 are required 

under § 1271.350(a)(1), and (b)(1) and 

(b)(2) to investigate and report to FDA 

adverse reactions (defined in 

§ 1271.3(y)) and HCT/P deviations 

(defined in § 1271.3(dd)). Section 

1271.370(b) and (c) requires 

establishments to include specific 

information either on the HCT/P label or 

in the package insert. 

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 received from other 

sources and for sharing information 

with consignees and other 

establishments); (2) section 1271.180(a) 

(to meet core CGTP requirements for all 

steps performed in the manufacture of 

HCT/Ps); (3) section 1271.190(d)(1) 

(facility cleaning and sanitization); (4) 

section 1271.200(b) (cleaning, 

sanitizing, and maintenance of 

equipment); (5) section 1271.200(c) 

(calibration of equipment); (6) section 

1271.230(a) (verification or validation of 

changes to a process); (7) section 

1271.250(a) (controls for labeling HCT/ 

Ps); (8) section 1271.265(e) (receipt, predistribution shipment, availability for 

distribution, and packaging and 

shipping of HCT/Ps); (9) section 

1271.265(f) (suitable for return to 

inventory); (10) section 1271.270(b) 

(records management system); (11) 

section 1271.290(b)(1) (system of HCT/ 

P tracking); and (12) section 1271.320(a) 

(review, evaluation, and documentation 

of all complaints). 

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 corrective actions taken as a result of 

an audit of the quality program. Section 

1271.160(b)(6) requires documentation 

of HCT/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 significant facility 

cleaning and sanitation. Section 

1271.195(d) requires documentation of 

environmental control and monitoring 

activities. Section 1271.200(e) requires 

documentation of all 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 acceptable storage 

conditions are not met and 

documentation of the storage 

temperature of HCT/Ps. 

Section 1271.265(c)(1) requires 

documentation that all release criteria 

are met before distribution of an HCT/ 

P. Section 1271.265(c)(3) requires 

documentation of any departure from a 

procedure at the time of occurrence. 

Section 1271.265(e) requires 

documentation of the receipt, predistribution shipment, distribution, and 

packaging and shipping of HCT/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 the 

establishment. Section 1271.290(d) and 

(e) requires documentation of a method 

for the recording and disposition of each 

HCT/P as part of its tracking system. 

Section 1271.320(b) requires an 

establishment to maintain a record of 

each complaint that it receives, 

including a review and evaluation. 

Respondents to this information 

collection are establishments that 

recover, process, store, label, package or 

distribute any HCT/P, or perform donor 

screening or testing. The estimates 

provided below are based on 

information from FDA’s database system 

and trade organizations for 2006. 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 2,017 HCT/P 

(conventional tissue, eye tissue, 

peripheral blood stem cell, stem cell 

products from cord blood, reproductive 

tissue, and sperm banks) 

establishments, including 481 

manufacturers of HCT/P products 

regulated under the Federal Food, Drug, 

and Cosmetic Act and section 351 of the 

PHS Act that have registered and listed 

with FDA. In addition, we estimate that 

241 new establishments have registered 

with FDA (§§ 1271.10(b)(1) and (b)(2) 

and 1271.25(a) and (b)). There are an 

estimated 3,289 listing updates 

(§§ 1271.10(b)(2), 1271.21(c)(2)(ii) and 

1271.25(c)) and 500 location/ownership 

amendments (§ 1271.26). 

Under § 1271.55(a), an estimated 

1,677,105 HCT/Ps (approximately 

1,500,000 conventional tissues, 44,186 

eye tissues, 7,919 hematopoetic stem 

cells/progenitor cells (total of 1,552,105 

non-reproductive cells and tissues), and 

125,000 reproductive cells and tissues) 

are distributed per year by an estimated 

1,536 establishments (2,017 - 481 

establishments with approved 

applications). Under § 1271.60(c), FDA 

estimates that 1,200 establishments 

shipped an estimated 250,000 HCT/P 

under quarantine, and that an estimated 

8 establishments requested an 

exemption from or alternative to any 

requirement under part 1271, subpart C 

or D, specifically under § 1271.155(a). 

Under §§ 1271.290(c) and 1271.370(b) 

and (c), the estimated 1,449 nonreproductive HCT/P establishments 


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Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21029 

label each of their 1,552,105 HCT/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 

§ 1271.290(f). 

FDA estimates 42 HCT/P 

establishments submitted 67 adverse 

reaction reports involving 

communicable disease 

(§ 1271.350(a)(1)), and 81 

establishments submitted 144 deviation 

reports relating to the core CGTP 

requirements (§ 1271.350(b)(1)). 

FDA estimates that 241 new 

establishments will create SOPs, and 

that 2,017 establishments will review 

and revise existing SOPs annually. 

FDA estimates that 1,009 HCT/P 

establishments (2,017 x 50% = 1,009) 

and 725 non-reproductive HCT/P 

establishments (1,449 x 50% = 725) 

record and justify a departure from the 

procedures (§ 1271.47(d) and 

§ 1271.265(c)(3)). 

Under § 1271.50(a), HCT/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 77,944 donors 

(approximately 23,295 conventional 

tissue donors, 42,649 eye tissue donors, 

7,000 peripheral and cord blood stem 

cell donors (72,944 non-reproductive 

cells and tissue donors), and 5,000 

reproductive cell and tissue donors). 

FDA estimates that 605 HCT/P 

establishments (2,017 x 30% = 605) 

document an urgent medical need of the 

product to notify the physician using 

the HCT/P (§§ 1271.60(d)(3) and 

1271.65(b)(3)).FDA also estimates that 

1614 HCT/P establishments (2,017 x 

80% = 1,614) have to maintain records 

for an average of 2 contract 

establishments to perform their 

manufacturing process (§ 1271.270(e)) 

and 1,009 HCT/P establishments 

maintain an average of 5 complaint 

records annually (§ 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. 

In the Federal Register of January 26, 

2007 (72 FR 3858), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1271.10(b)(1) and 1271.21(b)(2)2 2,017 1 2,017 0.5 1,009 

1271.21(a), and 1271.25(a) and (b)2 241 1 241 0.75 181 

1271.10(b)(2), 1271.21(c)(ii) and 

1271.25(c)2 3,289 1 3,289 0.5 1,644 

1271.262 500 1 500 0.25 125 

1271.55(a) 1,536 1,091.87 1,677,105 0.5 838,553 

1271.60(c) and (d)(2) 1,200 208.33 250,000 0.5 125,000 

1271.155(a) 8 1 8 3 24 

1271.290(c) 1,449 1,071.16 1,552,105 0.08 124,168.33 

1271.290(f) 1,449 1 1,449 1 1,449 

1271.350(a)(1) 42 1.60 67 1 67 

1271.350(b)(1) and (b)(2) 81 1.78 144 1 144 

1271.370(b) and (c) 1,449 1,071.16 1,552,105 0.25 388,026.25 

Total 1,480,390 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Using Form FDA 3356. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

New SOPs2 241 1 241 48 11,568 

SOP Update2 2,017 1 2,017 24 48,408 

1271.47(d) 1,009 1 1,009 1 1,009 


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21030 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1271.50(a) 2,017 38.64 77,944 5 389,720 

1271.55(d)(1) 2,017 38.64 77,944 1 77,944 

1271.55(d)(2) 2,017 1 2,017 1 2,017 

1271.55(d)(4) 2,017 1 2,017 120 242,040 

1271.60(d)(3) and 1271.65(b)(3) 605 1 605 2 1,210 

1271.155(f) 8 1 8 0.25 2 

1271.160(b)(3) and (b)(6) 1,449 12 17,388 1 17,388 

1271.160(d) 1,449 12 17,388 1 17,388 

1271.190(d)(2) 1,449 12 17,388 1 17,388 

1271.195(d) 1,449 12 17,388 1 17,388 

1271.200(e) 1,449 12 17,388 1 17,388 

1271.210(d) 1,449 12 17,388 1 17,388 

1271.230(a) 1,449 12 17,388 1 17,388 

1271.230(c) 1,449 1 1,449 1 1,449 

1271.260(d) 1,449 12 17,388 0.25 4,347 

1271.260(e) 1,449 365 528,885 0.08 42,310.8 

1271.265(c)(1) 1,449 1,071.16 1,552,105 0.08 124,168.33 

1271.265(c)(3) 725 1 725 1 725 

1271.265(e) 1,449 1,071.16 1,552,105 0.08 124,168.33 

1271.270(a) 1,449 1,071.16 1,552,105 0.25 388,026.25 

1271.270(e) 1,614 2 3,228 0.5 1,614 

1271.290(d) and (e) 1,449 50.34 72,944 0.25 18,236 

1271.320(b) 1,009 5 5,045 1 5,045 

Total 1,605,723.7 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2), 1271.180(a), 1271.190(d)(1), 1271.200(b) and (c), 1271.230(a), 1271.250(a),

1271.265(e), and 1271.320(a). 

Dated: April 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8038 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0149] 

Canned Pacific Salmon Deviating From 

Identity Standard; Temporary Permit 

for Market Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a temporary permit has been issued 

to Peter Pan Seafoods, Inc., to market 

test canned Pacific salmon that deviates 

from the U.S. standard of identity for 

canned Pacific salmon. The purpose of 

the temporary permit is to allow the 

applicant to measure consumer 

acceptance of the product and assess 

commercial feasibility. 

DATES: This permit is effective for 15 

months, beginning on the date the 

permit holder introduces or causes the 

introduction of the test product into 

interstate commerce, but not later than 

July 27, 2007. 

FOR FURTHER INFORMATION CONTACT: Ritu 

Nalubola, Center for Food Safety and 


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