Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61447 

submission of meeting requests and 

information packages under the 

guidance. 

C. Request For a Formal Meeting 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 713 sponsors and 

applicants (respondents) request 

approximately 1,783 formal meetings 

with CDER annually and approximately 

164 respondents request approximately 

286 formal meetings with CBER 

annually regarding the development and 

review of a PDUFA product. The hours 

per response, which is the estimated 

number of hours that a respondent 

would spend preparing the information 

to be submitted with a meeting request 

in accordance with the guidance, is 

estimated to be approximately 10 hours. 

Based on FDA’s experience, the agency 

expects it will take respondents this 

amount of time to gather and copy brief 

statements about the product and a 

description of the purpose and details of 

the meeting. 

D. Information Package 

Based on data collected from the 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately 615 respondents 

submitted approximately 1,365 

information packages to CDER annually 

and approximately 132 respondents 

submitted approximately 208 

information packages to CBER annually 

prior to a formal meeting regarding the 

development and review of a PDUFA 

product. The hours per response, which 

is the estimated number of hours that a 

respondent would spend preparing the 

information package in accordance with 

the guidance, is estimated to be 

approximately 18 hours. Based on 

FDA’s experience, the agency expects it 

will take respondents this amount of 

time to gather and copy brief statements 

about the product, a description of the 

details for the anticipated meeting, and 

data and information that generally 

would already have been compiled for 

submission to the agency. 

As stated earlier, the guidance 

provides information on how the agency 

will interpret and apply section 119(a) 

of the Modernization Act, specific 

PDUFA goals for the management of 

meetings associated with the review of 

human drug applications for PDUFA 

products, and provisions of existing 

regulations describing certain meetings 

(§§ 312.47 and 312.82). The information 

collection provisions in § 312.47 

concerning End of Phase 2 meetings and 

Pre NDA meetings have been approved 

by OMB (OMB control number 0910–

0014). However, the guidance provides 

additional recommendations for 

submitting information to FDA in 

support of a meeting request. As a 

result, FDA is submitting for OMB 

approval these additional estimates. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Meeting Requests and Information 

Packages 

Number of Respondents Number of Responses 

Per Respondent 

Total Annual Responses Hours Per Response Total Hours 

Meeting Requests 

CDER 713 2 .50 1,783 10 17,830 

CBER 164 1 .74 286 10 2,860 

Total 20,690 

Information Packages 

CDER 615 2 .22 1,365 18 24,570 

CBER 132 1 .58 208 18 3,744 

Total 28,314 

Grand Total 49,004 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21151 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0220] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practices and Related 

Regulations for Blood and Blood 

Components; and Requirements for 

Donor Testing, Donor Notification, and 

‘‘Lookback’’

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 November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written 

61448 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (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. 

Current Good Manufacturing Practices 

and Related Regulations for Blood and 

Blood Components; and Requirements 

for Donor Testing, Donor Notification, 

and ‘‘Lookback’’ (OMB Control Number 

0910–0116)—Extension 

Under the statutory requirements 

contained in section 351 of the Public 

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

262), no blood, blood component, or 

derivative may move in interstate 

commerce unless: (1) It is propagated or 

manufactured and prepared at an 

establishment holding an unsuspended 

and unrevoked license; (2) the product 

complies with regulatory standards 

designed to ensure safety, purity, and 

potency; and (3) it bears a label plainly 

marked with the product’s proper name, 

manufacturer, and expiration date. In 

addition, under the biologics licensing 

and quarantine provisions in sections 

351–361 of the PHS Act (42 U.S.C. 262–

264) and the general administrative 

provisions under sections 501–503, 

505–510, and 701–704 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

351–353, 355–360, and 371–374), FDA 

has the authority to issue and enforce 

regulations designed to protect the 

public from unsafe or ineffective 

biological products and to issue 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between States 

or possession or from foreign countries 

into the States or possession. The 

current good manufacturing practice 

(CGMP) and related regulations 

implement FDA’s statutory authority to 

ensure the safety, purity, and potency of 

blood and blood components. The 

‘‘lookback’’ requirements are intended 

to help ensure the continued safety of 

the blood supply by providing necessary 

information to users of blood and blood 

components and appropriate 

notification of recipients of transfusion 

who are at increased risk for 

transmitting human immunodeficiency 

virus (HIV) infection. The public health 

objective in testing human blood donors 

for evidence of infection due to 

communicable disease agents and in 

donor notification is to prevent the 

transmission of communicable disease. 

The information collection 

requirements in the CGMP, donor 

testing, donor notification, and 

‘‘lookback’’ regulations provide FDA 

with the necessary information to 

perform its duty to ensure the safety, 

purity, and potency of blood and blood 

components. These requirements 

establish accountability and traceability 

in the processing and handling of blood 

and blood components and enables FDA 

to conduct meaningful inspections. The 

recordkeeping requirements serve 

preventative and remedial purposes. 

The disclosure requirements identify 

the various blood and blood 

components and important properties of 

the product, demonstrate that the CGMP 

requirements have been met, and 

facilitate the tracing of a product back 

to its original source. The reporting 

requirements inform FDA of any 

deviations that occur and that may 

require immediate corrective action. 

Under the reporting requirements, 

§ 606.170(b) (21 CFR 606.170(b)) 

requires that fatal complications of 

blood collection and transfusions be 

reported to FDA as soon as possible and 

that a written report shall be submitted 

within 7 days. Section 610.40(c)(1)(ii) 

(21 CFR 610.40(c)(1)(ii)) requires each 

dedicated donation be labeled as 

required under 21 CFR 606.121 and 

with a label entitled ‘‘INTENDED 

RECIPIENT INFORMATION LABEL’’

containing the name and identifying 

information of the recipient. Section 

610.40(g)(2) requires an establishment to 

obtain written approval from FDA to 

ship human blood or blood components 

for further manufacturing use prior to 

completion of testing. Section 

610.40(h)(2)(ii)(A) requires an 

establishment to obtain written approval 

from FDA to use or ship human blood 

or blood components found to be 

reactive by a screening test for evidence 

of a communicable disease agent(s) or 

collect from a donor with a record of a 

reactive screening test. Sections 

610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) 

require an establishment to label 

reactive human blood and blood 

components with the appropriate 

screening test results, and, if they are 

intended for further manufacturing use 

into injectable products, with a 

statement indicating the exempted use 

specifically approved by FDA. Section 

610.40(h)(2)(vi) requires each donation 

of human blood or blood component 

that tests reactive by a screening test for 

syphilis and is determined to be a 

biological false positive be labeled with 

both test results. Section 610.42(a) (21 

CFR 610.42(a)) requires a warning 

statement, including the identity of the 

communicable disease agent, on 

medical devices containing human 

blood or blood components found to be 

reactive by a screening test for evidence 

of infection due to a communicable 

disease agent(s) or syphilis. Section 

610.46(a) (21 CFR 610.46(a)) requires 

blood establishments to notify 

consignees, within 72 hours, of 

repeatedly reactive test results so that 

previously collected blood and blood 

components are appropriately 

quarantined. Section 610.46(b) requires 

blood establishments to notify 

consignees of licensed, more specific 

test results for HIV within 30 calendar 

days after the donors’ repeatedly 

reactive test. Section 610.47(b) (21 CFR 

610.47(b)) requires transfusion services 

not subject to the Centers for Medicare 

and Medicaid Services (CMS) 

regulations to notify physicians of prior 

donation recipients or to notify 

recipients themselves of the need for 

HIV testing and counseling. Section 

630.6(a) (21 CFR 630.6(a)) requires an 

establishment to make reasonable 

attempts to notify any donor who has 

been deferred as required by § 610.41 

(21 CFR 610.41), or who has been 

determined not to be eligible as a donor. 

Section 630.6(d)(1) requires an 

establishment to provide certain 

information to the referring physician of 

an autologous donor who is deferred 

based on the results of tests as described 

in § 610.41. 

Under the recordkeeping 

requirements, § 606.100(b) (21 CFR 

606.100(b)) requires that written 

standard operating procedures (SOPs) 

be maintained for the collection, 

processing, compatibility testing, 

storage, and distribution of blood and 

blood components used for transfusion 

and manufacturing purposes. Section 

606.100(c) requires the review of all 

pertinent records to a lot or unit of 

blood prior to release. Any unexplained 

discrepancy or failure of a lot or unit of 

final product to meet any of its 

specifications must be thoroughly 

investigated, and the investigation, 

including conclusions and followup, 

must be recorded. Section 606.110(a) 

(21 CFR 606.110(a)) requires a physician 

to certify in writing that the donor’s 

health permits plateletpheresis or 

leukapheresis if a variance from 

additional regulatory standards for a 

specific product is used when obtaining 

the product from a specific donor for a 

specific recipient. Section 606.110(b) 

requires establishments to request prior 

Center for Biologics Evaluation and 

Research (CBER) approval for 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61449 

plasmapheresis of donors who do not 

meet donor requirements. The 

information collection requirements for 

§ 606.110(b) are reported and approved 

under OMB control number 0910–0338 

which expires August 31, 2005. Section 

606.151(e) (21 CFR 606.151(e)) requires 

that records of expedited transfusions in 

life-threatening emergencies be 

maintained. So that all steps in the 

collection, processing, compatibility 

testing, storage and distribution, quality 

control, and transfusion reaction reports 

and complaints for each unit of blood 

and blood components can be clearly 

traced, § 606.160 (21 CFR 606.160) 

requires that legible and indelible 

contemporaneous records of each 

significant step be made and maintained 

for no less than 5 years. Section 

606.160(b)(1)(ix) requires a facility to 

maintain records of notification of 

donors deferred or determined not to be 

eligible for donation, including 

appropriate followup if the initial 

notification attempt fails. Section 

606.160(b)(1)(xi) requires an 

establishment to maintain records of 

notification of the referring physician of 

a deferred autologous donor, including 

appropriate followup if the initial 

notification attempt fails. Section 

606.165 (21 CFR 606.165) requires that 

distribution and receipt records be 

maintained to facilitate recalls, if 

necessary. Section 606.170(a) requires 

records to be maintained of any reports 

of complaints of adverse reactions as a 

result of blood collection or transfusion. 

Each such report must be thoroughly 

investigated, and a written report, 

including conclusions and followup, 

must be prepared and maintained. 

Section 610.40(g)(1) requires an 

establishment to appropriately 

document a medical emergency for the 

release of human blood or blood 

components prior to completion of 

required testing. 

In addition to the CGMPs in part 606 

(21 CFR part 606), there are regulations 

in part 640 (21 CFR part 640) that 

require additional standards for certain 

blood and blood components as follows: 

Sections 640.3(a)(1), (a)(2), and (f); 

640.4(a)(1) and (a)(2); 640.25(b)(4) and 

(c)(1); 640.27(b); 640.31(b); 640.33(b); 

640.51(b); 640.53(b) and (c); 640.56(b) 

and (d); 640.61; 640.63(b)(3), (e)(1), and 

(e)(3); 640.65(b)(2); 640.66; 640.71(b)(1); 

640.72; 640.73; and 640.76(a) and (b). 

The information collection requirements 

and estimated burdens for these 

regulations are included in the part 606 

burden estimates, as described in Tables 

1 and 2 of this document. 

Respondents to this collection of 

information are licensed and unlicensed 

blood establishments that collect blood 

and blood components, including 

Source Plasma and Source Leukocytes 

inspected by FDA, and other transfusion 

services inspected by CMS. Based on 

information received from CBER’s 

database systems, there are 

approximately 81 licensed Source 

Plasma collection establishments with 

multiple locations and 1,628 registered 

Whole Blood collection establishments 

for a total of 1,709 establishments. There 

are approximately 2,156 registered 

blood establishments inspected by FDA. 

Of these establishments, approximately 

773 perform plateletpheresis and 

leukopheresis. These establishments 

annually collect approximately 28 

million units of Whole Blood, blood 

components including Source Plasma, 

and Source Leukocytes and are required 

to follow FDA ‘‘lookback’’ procedures, 

and approximately 134 are registered 

transfusion services that are not subject 

to CMS’s ‘‘lookback’’ regulations. Based 

on CMS records, there are an estimated 

4,980 transfusion services approved for 

Medicare reimbursement. 

The following reporting and 

recordkeeping estimates are based on 

information provided by industry, CMS, 

and FDA experience. Based on 

information received from industry, we 

estimate that there are an average of 13 

million donations of Source Plasma 

from approximately 2 million donors 

and 15 million donations of Whole 

Blood, including 300,000 (2 percent of 

15 million) autologous, from 

approximately 8 million donors. 

Assuming each autologous donor makes 

an average of 2 donations, FDA 

estimates that there are approximately 

150,000 autologous donors. 

FDA estimates that approximately 5 

percent (12,000) of the 240,000 

donations that are donated specifically 

for the use of an identified recipient 

would be tested under the dedicated 

donors testing provisions in 

§ 610.40(c)(1)(ii). 

Under § 610.40(g)(2) and (h)(2)(ii)(A), 

the only product currently shipped 

prior to completion of testing is a 

licensed product, Source Leukocytes, 

used in the manufacture of interferon, 

which requires rapid preparation from 

blood. Shipments of Source Leukocytes 

are preapproved under a biologics 

license application and each shipment 

does not have to be reported to the 

agency. Based on information from 

CBER’s database system, FDA receives 

an estimated 1 application per year from 

manufacturers of Source Leukocytes. 

Under § 610.40(h)(2)(ii)(C) and 

(h)(2)(ii)(D), FDA estimates that each 

manufacturer would ship an estimated 1 

human blood or blood component per 

month (12 per year) that would require 

two labels; one as reactive for the 

appropriate screening test under 

§ 610.40(h)(2)(ii)(C), and the other 

stating the exempted use specifically 

approved by FDA under 

§ 610.40(h)(2)(ii)(D). According to 

CBER’s database system, there are an 

estimated 40 licensed manufacturers 

that ship known reactive human blood 

or blood components. 

Based on information we received 

from industry, we estimate that 

approximately 18,000 donations 

annually test reactive by a screening test 

for syphilis, and are determined to be 

biological false positives by additional 

testing and labeled accordingly 

(§ 610.40(h)(2)(vi)). 

Human blood or a blood component 

with a reactive screening test, as a 

component of a medical device, is an 

integral part of the medical device, e.g., 

a positive control for an in vitro 

diagnostic testing kit. It is usual and 

customary business practice for 

manufacturers to include on the 

container label a warning statement that 

identifies the communicable disease 

agent. In addition, on the rare occasion 

when a human blood or blood 

component with a reactive screening 

test is the only component available for 

a medical device that does not require 

a reactive component, then a statement 

of warning is required to be affixed to 

the medical device. To account for this 

rare occasion under § 610.42(a), we 

estimate that the warning statement 

would be necessary no more than once 

a year. 

Based on information received from 

industry, we estimate that there are 

approximately 4,424 repeat donors that 

will test reactive on a screening test for 

HIV with 159 confirmed positive. We 

estimate that each repeat donor has 

donated two previous times and an 

average of three components were made 

from each donation. Under § 610.46(a) 

and (b), this estimate results in 26,544 

(4,424 x 2 x 3) notifications of the HIV 

screening test results to consignees by 

collecting establishments for the 

purpose of quarantining affected blood 

and blood components, and another 

26,544 (4,424 x 2 x 3) notifications to 

consignees of subsequent test results. 

Under § 610.47(b), based also on the 

information received from industry, we 

estimate that 80 percent of the 159 (127) 

confirmed HIV positive were from 

repeat donors of Whole Blood 

donations. 

Industry estimates that approximately 

13 percent of 10 million potential 

donors (1.3 million donors) who come 

to donate annually are determined not 

to be eligible for donation prior to 

collection because of failure to satisfy 

61450 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

eligibility criteria. It is the usual and 

customary business practice of 1,709 

collecting establishments to notify 

onsite and to explain the reason why the 

donor is determined not to be suitable 

for donating. Based on such available 

information, we estimate that two-thirds 

of the 1,709 collecting establishments 

provided onsite additional information 

and counseling to a donor determined 

not to be eligible for donation as usual 

and customary business practice. 

Consequently, we estimate that only 

one-third or 570 collection 

establishments would need to provide, 

under § 630.6(a), additional information 

and counseling onsite to the estimated 

433,333 (one-third of 1.3 million) 

ineligible donors. 

It is estimated that another 4.5 percent 

of 10 million donors (450,000 donors) 

are deferred annually based on test 

results. We estimate that currently 95 

percent of the establishments that 

collect 98 percent of the blood and 

blood components notify donors who 

have reactive test results for HIV, 

Hepatitis B Virus (HBV), Hepatitis C 

Virus (HCV), Human T-Lymphotropic 

Virus (HTLV), and syphilis as usual and 

customary business practice. 

Consequently, 5 percent (85) of the 

industry (1,709) collecting 2 percent 

(9,000) of the deferred donors (450,000) 

would notify donor under § 630.6(a). 

As part of usual and customary 

business practice, collecting 

establishments notify an autologous 

donor’s referring physician of reactive 

test results obtained during the donation 

process required under § 630.6(d)(1). 

However, we estimate that 5 percent of 

the 1,628 blood collection 

establishments (81) may not notify the 

referring physicians of the estimated 2 

percent of 150,000 autologous donors 

with reactive test results (3,000) as their 

usual and customary business practice. 

The recordkeeping chart reflects the 

estimate that 95 percent of the 

recordkeepers, which collect 98 percent 

of the blood supply, had developed 

SOPs as part of their customary and 

usual business practice. Establishments 

may minimize burdens associated with 

CGMP and related regulations by using 

model SOPs developed by industries’

accreditation organizations. These 

accreditation organizations represent 

almost all registered blood 

establishments. 

Under § 606.160(b)(1)(ix), we estimate 

the total annual records based on the 1.3 

million donors determined not to be 

eligible to donate and each of the 

450,000 (1,300,000 + 450,000 = 

1,750,000) donors deferred based on 

reactive test results for evidence of 

infection due to communicable disease 

agents. Under § 606.160(b)(1)(xi), only 

the 1,628 registered blood 

establishments collect autologous 

donations and, therefore, are required to 

notify referring physicians. We estimate 

that 4.5 percent of the 150,000 

autologous donors (6,750) will be 

deferred under § 610.41 and thus result 

in the notification of their referring 

physicians. 

FDA has concluded that the use of 

untested or incompletely tested but 

appropriately documented human blood 

or blood components in rare medical 

emergencies should not be prohibited. 

We estimate the recordkeeping under 

§ 610.40(g)(1) to be minimal with one or 

less occurrence per year. The reporting 

of test results to the consignee in 

§ 610.40(g) does not create a new burden 

for respondents because it is the usual 

and customary business practice or 

procedure to finish the testing and 

provide the results to the manufacturer 

responsible for labeling the blood 

products. 

The hours per response and hours per 

record are based on estimates received 

from industry or FDA experience with 

similar recordkeeping or reporting 

requirements. 

In the Federal Register of June 21, 

2005 (70 FR 35680), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

606.170(b)2 82 1 82 20 1,640 

610.40(c)(1)(ii) 1,628 8 12,000 0 .08 960 

610.40(g)(2) 1 1 1 1 1 

610.40(h)(2)(ii)(A) 1 1 1 1 1 

610.40(h)(2)(ii)(C) and 

(h)(2)(ii)(D) 40 12 480 0 .2 96 

610.40(h)(2)(vi) 1,628 11 18,000 0 .08 1,440 

610.42(a) 1 1 1 1 1 

610.46(a) 1,709 16 26,544 0 .17 4,512 

610.46(b) 1,709 16 26,544 0 .17 4,512 

610.47(b) 134 1 134 1 134 

630.6(a)3 570 760 433,333 0 .08 34,667 

630.6(a)4 85 106 9,000 1 .5 13,500 

630.6(d)(1) 81 37 3,000 1 3,000 

Total 64,464 

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

2The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b). 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61451 

3Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 

4Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

606.100(b)2 2495 1 249 24 5,976 

606.100(c) 2495 10 2,490 1 2,490 

606.110(a)3 396 1 39 0 .5 20 

606.151(e) 2495 12 2,988 0 .083 248 

606.1604 2495 1,928 480,000 0 .75 360,000 

606.160(b)(1)(ix) 1,709 1,024 1,750,000 0 .05 87,500 

606.160(b)(1)(xi) 1,628 4 6,750 0 .05 338 

606.165 2495 1,928 480,000 0 .083 39,840 

606.170(a) 2495 12 2,988 1 2,988 

610.40(g)(1) 1,628 1 1,628 0 .5 814 

Total 500,214 

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

2The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included 

in the estimate for § 606.110(a). 4The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and 

(c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the 

maintenance of various records are included in the estimate for § 606.160. 5Five percent of CMS transfusion services and FDA-registered blood establishments (0.05 X 4,980). 

6Five percent of plateletpheresis and leukopheresis establishments (0.05 X 773). 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21153 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0283] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Waivers of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by November 

23, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. 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: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

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. 

Waivers of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles 

The generic Animal Drug and Patent 

Term Registration Act of 1988 permitted 

generic drug manufacturers to copy 

those pioneer drug products that were 

no longer subject to patent or other 

marketing exclusivity protection. The 

approval for marketing these generic 

products is based in part upon a 

demonstration of bioequivalence 

between the generic product and 

pioneer product. This guidance clarifies 

circumstances under which FDA 

believes the demonstration of 

bioequivalence by the stature does not 

need to be established on the basis of in 

vivo studies for soluble powder oral 

dosage form products and Type A 

medicated articles. The data submitted 

in support of the waiver request are 

necessary to validate the waiver 

decision. 

The requirement to establish 

bioequivalence through in vivo studies 

(blood level bioequivalence or clinical 

endpoint bioequivalence) may be 

waived for soluble powder or Type A 

medicated articles in either of two