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Federal Register / Vol. 72, No.

79 / Wednesday, April 25, 2007 / Notices 20555

work of drafting the petition itself. The required for paper submissions. The DEPARTMENT OF HEALTH AND
burden varies depending on the agency estimates that one petitioner for HUMAN SERVICES
complexity of the petition, including the both food and color additives will take
amount and types of data needed for advantage of the electronic submission Food and Drug Administration
scientific analysis. process per year. By using the [Docket No. 2006N–0475]
Color additives are subjected to guidelines and forms that FDA is
payment of fees for the petitioning providing, the petitioner will be able to Agency Information Collection
process. The listing fee for a color organize the petition to focus on the Activities; Submission for Office of
additive petition ranges from $1,600 to Management and Budget Review;
information needed for FDA’s safety
$3,000, depending on the intended use Comment Request; Human Tissue
review. Therefore, we estimate that
of the color and the scope of the Intended for Transplantation
requested amendment. A complete petitioners will only need to spend
schedule of fees is set forth in 21 CFR approximately 1 hour completing the AGENCY: Food and Drug Administration,
70.19. An average of two category A and electronic submission application form HHS.
one category B color additive petitions (Form 3503 or 3504, as appropriate) ACTION: Notice.
are expected per year. The maximum because they will have already used the
color additive petition fee for a category guidelines to organize the petition SUMMARY: The Food and Drug
A petition is $2,600 and the maximum information needed for the submission. Administration (FDA) is announcing
color additive petition fee for a category that a proposed collection of
The labeling requirements for food
B petition is $3,000. Since an average of information has been submitted to the
and color additives were designed to Office of Management and Budget
3 color additive petitions are expected specify the minimum information
per calendar year, the estimated total (OMB) for review and clearance under
needed for labeling in order that food the Paperwork Reduction Act of 1995.
annual cost burden to petitioners for and color manufacturers may comply
this start-up cost would be less than or DATES: Fax written comments on the
with all applicable provisions of the act collection of information by May 25,
equal to $8,200 ((2 x $2,600) + (1 x
and other specific labeling acts 2007.
$3,000) = $8,200)). There are no capital
costs associated with color additive administered by FDA. Label information
does not require any additional ADDRESSES: To ensure that comments on
petitions. the information collection are received,
The estimated burden reported in information gathering beyond what is
OMB recommends that written
table 1 of this document does not already required to assure conformance
comments be faxed to the Office of
include the previously estimated burden with all specifications and limitations in
Information and Regulatory Affairs,
for the preparation of FAPs submitted to any given food or color additive
OMB, Attn: FDA Desk Officer, FAX:
amend parts 175 through 178 (21 CFR regulation. Label information does not 202–395–6974. All comments should be
parts 175 through 178). The burden to have any specific recordkeeping identified with the OMB control number
respondents is similar between the requirements unique to preparing the 0910–0302. Also include the FDA
preparation of petitions submitted to label. Therefore, because under § 70.25, docket number found in brackets in the
amend parts 175 through 178 and the labeling requirements for a particular heading of this document.
preparation of a food contact substance color additive involve information FOR FURTHER INFORMATION CONTACT:
notification. In this request for required as part of the CAP safety
extension of OMB approval for the Jonna Capezzuto, Office of the Chief
review process, the estimate for number Information Officer (HFA–250), Food
collection of information for FAPs, FDA of respondents is the same for §§ 70.25
proposes to transfer the collection of and Drug Administration, 5600 Fishers
and 71.1, and the burden hours for Lane, Rockville, MD 20857, 301–827–
information and burden associated with labeling are included in the estimate for
petitions submitted to amend the 4659.
§ 71.1. Also, because labeling SUPPLEMENTARY INFORMATION: In
indirect food additive regulations (parts
175 through 178) from this collection of requirements under parts 172, 173, 179, compliance with 44 U.S.C. 3507, FDA
information (OMB control number and 180 for particular food additives has submitted the following proposed
0910–0016) to the existing collection of involve information required as part of collection of information to OMB for
information for the Food Contact the FAP safety review process under review and clearance.
Substances Notification System (OMB § 171.1, the burden hours for labeling
are included in the estimate for § 171.1. Human Tissue Intended for
control number 0910–0495).
FDA estimates the annual reporting Transplantation (OMB Control Number
In cases where a regulation 0910–0302)—Extension
burden associated with petitions implements a statutory information
submitted to amend parts 175 through collection requirement, only the Under section 361 of the Public
178 to be transferred from OMB control additional burden attributable to the Health Service (PHS) Act (42 U.S.C.
number 0910–0016 to OMB control regulation, if any, has been included in 264), FDA issued regulations to prevent
number 0910–0495. An average of two the transmission of human
FDA’s burden estimate.
indirect food additive petitions are immunodeficiency virus (HIV), hepatitis
expected per calendar year. The Dated: April 18, 2007. B, and hepatitis C, through the use of
estimated total annual hour burden to Jeffrey Shuren, human tissue for transplantation. The
petitioners per petition is 10,995 hours, Assistant Commissioner for Policy. regulations provide for inspection by
for a total burden of 21,990 hours. There [FR Doc. E7–7813 Filed 4–24–07; 8:45 am] FDA of persons and tissue
are no capital costs or operating and establishments engaged in the recovery,
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maintenance costs associated with the screening, testing, processing, storage,
burden hours being transferred from or distribution of human tissue. These
OMB control number 0910–0016 to facilities are required to meet provisions
OMB control number 0910–0495. intended to ensure appropriate
Electronic submissions of petitions screening and testing of human tissue
contain the same petition information donors and to ensure that records are

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20556 Federal Register / Vol. 72, No. 79 / Wednesday, April 25, 2007 / Notices

kept documenting that the appropriate tissue intended for transplantation. procedures (SOPs) under § 1270.31(a)
screening and testing have been Based on information from the Center through (d). The requirement for the
completed. for Biologics Evaluation and Research’s development of these written
Sections 1270.31(a) through (d) (21 (CBER’s) database system, FDA procedures is considered an initial one-
CFR 1270.31(a) through (d)) require estimates that there are approximately time burden. FDA assumes that all
written procedures to be prepared and 190 tissue establishments, of which 105 current tissue establishments have
followed for the following steps: (1) All are conventional tissue banks and 85 are developed written procedures in
significant steps in the infectious eye tissue banks. Based on information compliance with part 1270. Therefore,
disease testing process; (2) all provided by industry, there are an their information collection burden is
significant steps in obtaining, reviewing, estimated total of 1,500,000 for the general review and update of
and assessing the relevant medical conventional tissue products and 84,789 written procedures estimated to take an
records of the donor; (3) designating and eye tissue products recovered per year annual average of 24 hours, and for the
identifying quarantined tissue; and (4) with an average of 25 percent of the
for prevention of infectious disease recording and justifying of any
tissue discarded due to unsuitability for
contamination or cross-contamination deviations from the written procedures
transplant. In addition, there are an
by tissue during processing. Sections estimated 23,295 donors of conventional for § 1270.31(a) and (b), estimated to
1270.31(a) and (b) also require recording tissue and 42,649 donors of eye tissue take an annual average of 1 hour. The
and justification of any deviation from each year. information collection burden for
the written procedures. Section Accredited members of the American maintaining records concurrently with
1270.33(a) (21 CFR 1270.33(a)) requires Association of Tissue Banks (AATB) the performance of each significant
records to be maintained concurrently and Eye Bank Association of America screening and testing step and for
with the performance of each significant (EBAA) adhere to standards of those retaining records for 10 years under
step in the procedures of infectious organizations that are comparable to the § 1270.33(a), (f), and (h), include
disease screening and testing of human recordkeeping requirement in 21 CFR documenting the results and
tissue donors. Section 1270.33(f) part 1270. Based on information interpretation of all required infectious
requires records to be retained regarding provided by CBER’s database system, 76 disease tests and results and the identity
the determination of the suitability of percent of the conventional tissue banks and relevant medical records of the
the donors and such records required are members of AATB (105 x 76 percent donor required under § 1270.35(a) and
under § 1270.21 (21 CFR 1270.21). = 80), and 96 percent of eye tissue banks (b). Therefore, the burden under these
Section 1270.33(h) requires all records are members of EBAA (85 x 96 percent provisions is calculated together in table
be retained at least 10 years beyond the = 82). Therefore, recordkeeping by these 1 of this document. The recordkeeping
date of transplantation, distribution, 162 establishments (80 + 82 = 162) is estimates for the number of total annual
disposition, or expiration of the tissue, excluded from the burden estimates as records and hours per record are based
whichever is the latest. Section 1270.35 usual and customary business activities on information provided by industry
(21 CFR 1270.35) requires specific (5 CFR 1320.3(b)(2)). The recordkeeping and FDA experience.
records be maintained to document the burden, thus, is estimated for the
following: (1) The results and remaining 28 establishments, which is In the Federal Register of December 4,
interpretation of all required infectious 15 percent of all establishments (190 - 2006 (71 FR 70410), FDA published a
disease tests, (2) information on the 162 = 28, or 28/190 = 15 percent). 60-day notice on human tissue intended
identity and relevant medical records of Based on CBER’s database system and for transplantation requesting public
the donor, (3) the receipt and/or information provided by industry, FDA comment on the information collection
distribution of human tissue, and (4) the estimates an average of two new tissue provisions. No comments were received.
destruction or other disposition of banks annually, which may be non- The notice contained an error in the
human tissue. members of a trade association. Each third line of the table for estimated
Respondents to this collection of new tissue bank requires an estimated annual recordkeeping burden. The
information are manufacturers of human 64 hours to prepare standard operating following table corrects that error.


No. of Record- Annual Frequency per
21 CFR Section Total Annual Records Hours per Record Total Hours
keepers Recordkeeping

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

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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. utility, and clarity of the information to would be issued pursuant to section
Jeffrey Shuren, be collected; and (4) Minimize the 10(a)(1)(A) of the Endangered Species
Assistant Commissioner for Policy. burden of the collection of information Act of 1973, as amended (Act). The
[FR Doc. E7–7815 Filed 4–24–07; 8:45 am] on those who are to respond; including applications were developed in
the use of appropriate automated conjunction with a Template Safe
collection techniques or other forms of Harbor Agreement (Template SHA) for
information technology, e.g., permitting the Columbia Basin pygmy rabbit
electronic submission of responses. (Brachylagus idahoensis). The thirteen
This Notice also lists the following permit applicants are: (1) Mr. Raymond
information: Mayer; (2) Rimrock Meadows
[Docket No. FR–5121–N–13] Title of Proposal: Multifamily Project Association; (3) ABS Farms LLC; (4)
Monthly Accounting Reports. Sagebrush Flats Farm; (5) Mr. Eric Long;
Notice of Proposed Information OMB Control Number, if applicable: (6) Mr. W. Paul Malone; (7) Tom Davis
Collection: Comment Request; 2502–0108. Farms J.V.; (8) Mr. Dale Pixlee; (9)
Multifamily Project Monthly Description of the need for the Clements Farm, Inc.—JBS Farms; (10)
Accounting Reports information and proposed use: This Heer Brothers J.V.; (11) Mr. Don Roberts;
information is necessary for HUD to (12) David Adams Family LLC; and (13)
AGENCY: Office of the Assistant monitor compliance with contractual
Secretary for Housing—Federal Housing Evans Brothers J.V. Issuance of permits
agreements and to analyze cash flow to these applicants would exempt
Commissioner, HUD. trends as well as occupancy and rent incidental take of the Columbia Basin
ACTION: Notice. collection levels. pygmy rabbit, which would otherwise
Agency form numbers, if applicable: be prohibited by section 9 of the Act,
SUMMARY: The proposed information
HUD–93479, HUD–93480, HUD–93481. that is above the baseline conditions of
collection requirement described below Estimation of the total numbers of
will be submitted to the Office of properties enrolled under the Template
hours needed to prepare the information SHA, and that may result from the
Management and Budget (OMB) for collection including number of
review, as required by the Paperwork permittees’ otherwise lawful land-use
respondents, frequency of response, and activities. The Service requests
Reduction Act. The Department is hours of response: The estimated comments from the public regarding the
soliciting public comments on the number of respondents is 14.758; the proposed issuance of permits to these
subject proposal. estimated number of responses is 2,952; thirteen applicants. Before including
DATES: Comments Due Date: June 25, the frequency of responses is 12; your address, phone number, e-mail
2007. estimated time to gather and prepare the address, or other personal identifying
ADDRESSES: Interested persons are necessary documents (combined for all information in your comment, you
invited to submit comments regarding documents) is 3.50 hours per should be aware that your entire
this proposal. Comments should refer to submission, and the estimated total comment—including your personal
the proposal by name and/or OMB annual burden hours are 123,984. identifying information—may be made
Control Number and should be sent to: Status of the proposed information publicly available at any time. While
Lillian Deitzer, Reports Management collection: Extension of a currently you can ask us in your comment to
Officer, Department of Housing and approved collection. withhold your personal identifying
Urban Development, 451 7th Street, Authority: The Paperwork Reduction Act information from public review, we
SW., Room 4178, Washington, DC 20410 of 1995, 44 U.S.C., Chapter 35, as amended. cannot guarantee that we will be able to
or Dated: April 20, 2007. do so.
FOR FURTHER INFORMATION CONTACT: Frank L. Davis, DATES: To be fully considered, written
Kimberly Munson, Office of Asset General Deputy Assistant Secretary for comments from interested parties must
Management, Policy and Participation Housing—Deputy Federal Housing be received on or before May 25, 2007.
Standards Division, Department of Commissioner. ADDRESSES: Written comments
Housing and Urban Development, 451 [FR Doc. E7–7922 Filed 4–24–07; 8:45 am] concerning this notice should be
7th Street, SW., Washington, DC 20410, BILLING CODE 4210–67–P addressed to Susan Martin, Supervisor,
telephone number (202) 708–1320 (this U.S. Fish and Wildlife Service, Upper
is not a toll-free number). Columbia Fish and Wildlife Office,
Department is submitting the proposed Washington 99206. You may also send
information collection to OMB for Fish and Wildlife Service comments by facsimile, at (509) 891–
review, as required by the Paperwork 6748, or by electronic mail, at:
Reduction Act of 1995 (44 U.S.C. Receipt of Applications for
Chapter 35, as amended). Endangered Species Act Enhancement FOR FURTHER INFORMATION CONTACT:
This Notice is soliciting comments of Survival Permits Developed in Chris Warren at (509) 893–8020, or
from members of the public and affected Accordance With a Template Safe Michelle Eames at (509) 893–8010.
agencies concerning the proposed Harbor Agreement for the Columbia
collection of information to: (1) Evaluate Basin Pygmy Rabbit
whether the proposed collection is Availability of Documents
AGENCY: Fish and Wildlife Service,
necessary for the proper performance of Interior. Copies of the thirteen permit
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the functions of the agency, including ACTION: Notice of receipt of applications. applications, the final Template SHA,
whether the information will have and other relevant documents are
practical utility; (2) Evaluate the SUMMARY: The U.S. Fish and Wildlife available for public inspection, by
accuracy of the agency’s estimate of the Service (Service) announces the receipt appointment, during normal business
burden of the proposed collection of of thirteen applications for hours at the Upper Columbia Fish and
information; (3) Enhance the quality, enhancement of survival permits that Wildlife Office (see ADDRESSES), or they

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