9226 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

these in the development of effective 

risk communications; (2) more 

efficiently and effectively design 

messages and select formats that have 

the greatest potential to influence the 

target audience’s attitudes and behavior 

in a favorable way; (3) determine the 

best promotion and distribution 

channels to reach the target audience 

with appropriate messages; and (4) 

expend limited program resource 

dollars wisely and effectively. 

Frequency of Response: On occasion. 

Affected Public: Individuals or 

households; Type of Respondents: 

Members of the public, healthcare 

professionals; organizational 

representatives. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Type of Respondents No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Adolescents 13–17, and Adults 18+ 16,448 1 16,448 0.1739 2,860 

Total 2,860 

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

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4098 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0066] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Human Tissue 

Intended for Transplantation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 

relating to FDA regulations for human 

tissue intended for transplantation. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 30, 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) 

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 Tissue Intended for 

Transplantation—21 CFR Part 1270 

(OMB Control Number 0910–0302)— 

Extension 

Under section 361 of the Public 

Health Service (PHS) Act (42 U.S.C. 

264), FDA issued regulations under part 

1270 (21 CFR part 1270) to prevent the 

transmission of human 

immunodeficiency virus (HIV), hepatitis 

B, and hepatitis C through the use of 

human tissue for transplantation. The 

regulations provide for inspection by 

FDA of persons and tissue 

establishments engaged in the recovery, 

screening, testing, processing, storage, 

or distribution of human tissue. These 

facilities are required to meet provisions 

intended to ensure appropriate 

screening and testing of human tissue 

donors and to ensure that records are 

kept documenting that the appropriate 

screening and testing have been 

completed. 

Section 1270.31(a) through (d) 

requires written procedures to be 

prepared and followed for the following 

steps: (1) All significant steps in the 

infectious disease testing process under 

§ 1270.21; (2) all significant steps for 

obtaining, reviewing, and assessing the 

relevant medical records of the donor as 

prescribed in § 1270.21; (3) designating 

and identifying quarantined tissue; and 

(4) for prevention of infectious disease 

contamination or cross-contamination 

by tissue during processing. Section 

1270.31(a) and (b) also requires 

recording and justification of any 

deviation from the written procedures. 

Section 1270.33(a) requires records to be 

maintained concurrently with the 

performance of each significant step in 

the performance of infectious disease 

screening and testing of human tissue 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 9227 

donors. Section 1270.33(f) requires 

records to be retained regarding the 

determination of the suitability of the 

donors and such records required under 

§ 1270.21. Section 1270.33(h) requires 

all records to be retained at least 10 

years beyond the date of transplantation 

if known, distribution, disposition, or 

expiration of the tissue, whichever is 

the latest. Section 1270.35(a) through (d) 

requires specific records to be 

maintained to document the following: 

(1) The results and interpretation of all 

required infectious disease tests, (2) 

information on the identity and relevant 

medical records of the donor, (3) the 

receipt and/or distribution of human 

tissue, and (4) the destruction or other 

disposition of human tissue. 

Respondents to this collection of 

information are manufacturers of human 

tissue intended for transplantation. 

Based on information from the Center 

for Biologics Evaluation and Research’s 

(CBER’s) database system, FDA 

estimates that there are approximately 

257 tissue establishments of which 145 

are conventional tissue banks and 112 

are eye tissue banks. Based on 

information provided by industry, there 

are an estimated total of 1,959,270 

conventional tissue products and 82,741 

eye tissue products recovered per year 

with an average of 25 percent of the 

tissue discarded due to unsuitability for 

transplant. In addition, there are an 

estimated 57,275 donors of conventional 

tissue and 54,115 donors of eye tissue 

each year. 

Accredited members of the American 

Association of Tissue Banks (AATB) 

and Eye Bank Association of America 

(EBAA) adhere to standards of those 

organizations that are comparable to the 

recordkeeping requirements in part 

1270. Based on information provided by 

CBER’s database system, 90 percent of 

the conventional tissue banks are 

members of AATB (145 x 90% = 130), 

and 77 percent of eye tissue banks are 

members of EBAA (112 x 77% = 86). 

Therefore, recordkeeping by these 216 

establishments (130 + 86 = 216) is 

excluded from the burden estimates as 

usual and customary business activities 

(5 CFR 1320.3(b)(2)). The recordkeeping 

burden, thus, is estimated for the 

remaining 41 establishments, which is 

16 percent of all establishments (257 - 

216 = 41, or 41/257 = 16%). 

FDA assumes that all current tissue 

establishments have developed written 

procedures in compliance with part 

1270. Therefore, their information 

collection burden is for the general 

review and update of written 

procedures estimated to take an annual 

average of 24 hours, and for the 

recording and justifying of any 

deviations from the written procedures 

for § 1270.31(a) and (b), estimated to 

take an annual average of 1 hour. The 

information collection burden for 

maintaining records concurrently with 

the performance of each significant 

screening and testing step and for 

retaining records for 10 years under 

§ 1270.33(a), (f), and (h), include 

documenting the results and 

interpretation of all required infectious 

disease tests and results and the identity 

and relevant medical records of the 

donor required under § 1270.35(a) and 

(b). Therefore, the burden under these 

provisions is calculated together in table 

1 of this document. The recordkeeping 

estimates for the number of total annual 

records and hours per record are based 

on information provided by industry 

and FDA experience. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Response Total Hours 

1270.31(a), (b), (c), and (d)2 41 1 41 24 984 

1270.31(a) and (b)3 41 2 82 1 82 

1270.33(a), (f), and (h) and 

1270.35(a) and (b) 41 8,404 344,564 1 344,564 

1270.35(c) 41 15,938 653,458 1 653,458 

1270.35(d) 41 1,992 81,672 1 81,672 

Total 1,080,760 

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

2 Review and update of SOPs. 

3 Documentation of deviations from SOPs. 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4066 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0206] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FIRMAGON 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

FIRMAGON and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

mstockstill on DSKH9S0YB1PROD with NOTICES