Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 20555 

work of drafting the petition itself. The 

burden varies depending on the 

complexity of the petition, including the 

amount and types of data needed for 

scientific analysis. 

Color additives are subjected to 

payment of fees for the petitioning 

process. The listing fee for a color 

additive petition ranges from $1,600 to 

$3,000, depending on the intended use 

of the color and the scope of the 

requested amendment. A complete 

schedule of fees is set forth in 21 CFR 

70.19. An average of two category A and 

one category B color additive petitions 

are expected per year. The maximum 

color additive petition fee for a category 

A petition is $2,600 and the maximum 

color additive petition fee for a category 

B petition is $3,000. Since an average of 

3 color additive petitions are expected 

per calendar year, the estimated total 

annual cost burden to petitioners for 

this start-up cost would be less than or 

equal to $8,200 ((2 x $2,600) + (1 x 

$3,000) = $8,200)). There are no capital 

costs associated with color additive 

petitions. 

The estimated burden reported in 

table 1 of this document does not 

include the previously estimated burden 

for the preparation of FAPs submitted to 

amend parts 175 through 178 (21 CFR 

parts 175 through 178). The burden to 

respondents is similar between the 

preparation of petitions submitted to 

amend parts 175 through 178 and the 

preparation of a food contact substance 

notification. In this request for 

extension of OMB approval for the 

collection of information for FAPs, FDA 

proposes to transfer the collection of 

information and burden associated with 

petitions submitted to amend the 

indirect food additive regulations (parts 

175 through 178) from this collection of 

information (OMB control number 

0910–0016) to the existing collection of 

information for the Food Contact 

Substances Notification System (OMB 

control number 0910–0495). 

FDA estimates the annual reporting 

burden associated with petitions 

submitted to amend parts 175 through 

178 to be transferred from OMB control 

number 0910–0016 to OMB control 

number 0910–0495. An average of two 

indirect food additive petitions are 

expected per calendar year. The 

estimated total annual hour burden to 

petitioners per petition is 10,995 hours, 

for a total burden of 21,990 hours. There 

are no capital costs or operating and 

maintenance costs associated with the 

burden hours being transferred from 

OMB control number 0910–0016 to 

OMB control number 0910–0495. 

Electronic submissions of petitions 

contain the same petition information 

required for paper submissions. The 

agency estimates that one petitioner for 

both food and color additives will take 

advantage of the electronic submission 

process per year. By using the 

guidelines and forms that FDA is 

providing, the petitioner will be able to 

organize the petition to focus on the 

information needed for FDA’s safety 

review. Therefore, we estimate that 

petitioners will only need to spend 

approximately 1 hour completing the 

electronic submission application form 

(Form 3503 or 3504, as appropriate) 

because they will have already used the 

guidelines to organize the petition 

information needed for the submission. 

The labeling requirements for food 

and color additives were designed to 

specify the minimum information 

needed for labeling in order that food 

and color manufacturers may comply 

with all applicable provisions of the act 

and other specific labeling acts 

administered by FDA. Label information 

does not require any additional 

information gathering beyond what is 

already required to assure conformance 

with all specifications and limitations in 

any given food or color additive 

regulation. Label information does not 

have any specific recordkeeping 

requirements unique to preparing the 

label. Therefore, because under § 70.25, 

labeling requirements for a particular 

color additive involve information 

required as part of the CAP safety 

review process, the estimate for number 

of respondents is the same for §§ 70.25 

and 71.1, and the burden hours for 

labeling are included in the estimate for 

§ 71.1. Also, because labeling 

requirements under parts 172, 173, 179, 

and 180 for particular food additives 

involve information required as part of 

the FAP safety review process under 

§ 171.1, the burden hours for labeling 

are included in the estimate for § 171.1. 

In cases where a regulation 

implements a statutory information 

collection requirement, only the 

additional burden attributable to the 

regulation, if any, has been included in 

FDA’s burden estimate. 

Dated: April 18, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–7813 Filed 4–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0475] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Tissue 

Intended for Transplantation 

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 25, 

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 

0910–0302. 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 Tissue Intended for 

Transplantation (OMB Control Number 

0910–0302)—Extension 

Under section 361 of the Public 

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

264), FDA issued regulations 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 


cprice-sewell on PRODPC61 with NOTICES
20556 Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 

kept documenting that the appropriate 

screening and testing have been 

completed. 

Sections 1270.31(a) through (d) (21 

CFR 1270.31(a) through (d)) require 

written procedures to be prepared and 

followed for the following steps: (1) All 

significant steps in the infectious 

disease testing process; (2) all 

significant steps in obtaining, reviewing, 

and assessing the relevant medical 

records of the donor; (3) designating and 

identifying quarantined tissue; and (4) 

for prevention of infectious disease 

contamination or cross-contamination 

by tissue during processing. Sections 

1270.31(a) and (b) also require recording 

and justification of any deviation from 

the written procedures. Section 

1270.33(a) (21 CFR 1270.33(a)) requires 

records to be maintained concurrently 

with the performance of each significant 

step in the procedures of infectious 

disease screening and testing of human 

tissue 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 (21 CFR 1270.21). 

Section 1270.33(h) requires all records 

be retained at least 10 years beyond the 

date of transplantation, distribution, 

disposition, or expiration of the tissue, 

whichever is the latest. Section 1270.35 

(21 CFR 1270.35) requires specific 

records 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 

190 tissue establishments, of which 105 

are conventional tissue banks and 85 are 

eye tissue banks. Based on information 

provided by industry, there are an 

estimated total of 1,500,000 

conventional tissue products and 84,789 

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 23,295 donors of conventional 

tissue and 42,649 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 requirement in 21 CFR 

part 1270. Based on information 

provided by CBER’s database system, 76 

percent of the conventional tissue banks 

are members of AATB (105 x 76 percent 

= 80), and 96 percent of eye tissue banks 

are members of EBAA (85 x 96 percent 

= 82). Therefore, recordkeeping by these 

162 establishments (80 + 82 = 162) 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 28 establishments, which is 

15 percent of all establishments (190 - 

162 = 28, or 28/190 = 15 percent). 

Based on CBER’s database system and 

information provided by industry, FDA 

estimates an average of two new tissue 

banks annually, which may be nonmembers of a trade association. Each 

new tissue bank requires an estimated 

64 hours to prepare standard operating 

procedures (SOPs) under § 1270.31(a) 

through (d). The requirement for the 

development of these written 

procedures is considered an initial onetime burden. 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. 

In the Federal Register of December 4, 

2006 (71 FR 70410), FDA published a 

60-day notice on human tissue intended 

for transplantation requesting public 

comment on the information collection 

provisions. No comments were received. 

The notice contained an error in the 

third line of the table for estimated 

annual recordkeeping burden. The 

following table corrects that error. 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers 

Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours 

1270.31(a), (b), (c), and (d) 28 1 2 64 128 

1270.31(a), (b), (c), and (d)2 28 1 28 24 672 

1270.31(a) and 1270.31(b)3 28 2 56 1 56 

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

1270.35(a) and (b) 28 8,843 247,610 1 247,610 

1270.35(c) 28 16,980 475,436 1 475,436 

1270.35(d) 28 2,123 59,430 1 59,430 

Total 783,332 

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

2Review and update of SOPs. 

3Documentation of deviations from SOPs. 


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Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices 20557 

Dated: April 18, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–7815 Filed 4–24–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5121–N–13] 

Notice of Proposed Information 

Collection: Comment Request; 

Multifamily Project Monthly 

Accounting Reports 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

will be submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

DATES: Comments Due Date: June 25, 

2007. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

Lillian Deitzer, Reports Management 

Officer, Department of Housing and 

Urban Development, 451 7th Street, 

SW., Room 4178, Washington, DC 20410 

or Lillian_L_Deitzer@HUD.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Munson, Office of Asset 

Management, Policy and Participation 

Standards Division, Department of 

Housing and Urban Development, 451 

7th Street, SW., Washington, DC 20410, 

telephone number (202) 708–1320 (this 

is not a toll-free number). 

SUPPLEMENTARY INFORMATION: The 

Department is submitting the proposed 

information collection to OMB for 

review, as required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35, as amended). 

This Notice is soliciting comments 

from members of the public and affected 

agencies concerning the proposed 

collection of information to: (1) Evaluate 

whether the proposed collection is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

the use of appropriate automated 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of responses. 

This Notice also lists the following 

information: 

Title of Proposal: Multifamily Project 

Monthly Accounting Reports. 

OMB Control Number, if applicable: 

2502–0108. 

Description of the need for the 

information and proposed use: This 

information is necessary for HUD to 

monitor compliance with contractual 

agreements and to analyze cash flow 

trends as well as occupancy and rent 

collection levels. 

Agency form numbers, if applicable: 

HUD–93479, HUD–93480, HUD–93481. 

Estimation of the total numbers of 

hours needed to prepare the information 

collection including number of 

respondents, frequency of response, and 

hours of response: The estimated 

number of respondents is 14.758; the 

estimated number of responses is 2,952; 

the frequency of responses is 12; 

estimated time to gather and prepare the 

necessary documents (combined for all 

documents) is 3.50 hours per 

submission, and the estimated total 

annual burden hours are 123,984. 

Status of the proposed information 

collection: Extension of a currently 

approved collection. 

Authority: The Paperwork Reduction Act 

of 1995, 44 U.S.C., Chapter 35, as amended. 

Dated: April 20, 2007. 

Frank L. Davis, 

General Deputy Assistant Secretary for 

Housing—Deputy Federal Housing 

Commissioner. 

[FR Doc. E7–7922 Filed 4–24–07; 8:45 am] 

BILLING CODE 4210–67–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

Receipt of Applications for 

Endangered Species Act Enhancement 

of Survival Permits Developed in 

Accordance With a Template Safe 

Harbor Agreement for the Columbia 

Basin Pygmy Rabbit 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of receipt of applications. 

SUMMARY: The U.S. Fish and Wildlife 

Service (Service) announces the receipt 

of thirteen applications for 

enhancement of survival permits that 

would be issued pursuant to section 

10(a)(1)(A) of the Endangered Species 

Act of 1973, as amended (Act). The 

applications were developed in 

conjunction with a Template Safe 

Harbor Agreement (Template SHA) for 

the Columbia Basin pygmy rabbit 

(Brachylagus idahoensis). The thirteen 

permit applicants are: (1) Mr. Raymond 

Mayer; (2) Rimrock Meadows 

Association; (3) ABS Farms LLC; (4) 

Sagebrush Flats Farm; (5) Mr. Eric Long; 

(6) Mr. W. Paul Malone; (7) Tom Davis 

Farms J.V.; (8) Mr. Dale Pixlee; (9) 

Clements Farm, Inc.—JBS Farms; (10) 

Heer Brothers J.V.; (11) Mr. Don Roberts; 

(12) David Adams Family LLC; and (13) 

Evans Brothers J.V. Issuance of permits 

to these applicants would exempt 

incidental take of the Columbia Basin 

pygmy rabbit, which would otherwise 

be prohibited by section 9 of the Act, 

that is above the baseline conditions of 

properties enrolled under the Template 

SHA, and that may result from the 

permittees’ otherwise lawful land-use 

activities. The Service requests 

comments from the public regarding the 

proposed issuance of permits to these 

thirteen applicants. Before including 

your address, phone number, e-mail 

address, or other personal identifying 

information in your comment, you 

should be aware that your entire 

comment—including your personal 

identifying information—may be made 

publicly available at any time. While 

you can ask us in your comment to 

withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

DATES: To be fully considered, written 

comments from interested parties must 

be received on or before May 25, 2007. 

ADDRESSES: Written comments 

concerning this notice should be 

addressed to Susan Martin, Supervisor, 

U.S. Fish and Wildlife Service, Upper 

Columbia Fish and Wildlife Office, 

11103 East Montgomery Drive, Spokane, 

Washington 99206. You may also send 

comments by facsimile, at (509) 891–

6748, or by electronic mail, at: 

fw1cbprabbit@fws.gov. 

FOR FURTHER INFORMATION CONTACT: 

Chris Warren at (509) 893–8020, or 

Michelle Eames at (509) 893–8010. 

SUPPLEMENTARY INFORMATION: 

Availability of Documents 

Copies of the thirteen permit 

applications, the final Template SHA, 

and other relevant documents are 

available for public inspection, by 

appointment, during normal business 

hours at the Upper Columbia Fish and 

Wildlife Office (see ADDRESSES), or they 


cprice-sewell on PRODPC61 with NOTICES