Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 57943

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21673 Filed 9–23–04; 3:08 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0367]

Cumulative List of Exceptions and 

Alternative Procedures Approved by 

the Director of the Center for Biologics 

Evaluation and Research

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability a cumulative list of 

exceptions and alternative procedures to 

requirements regarding blood, blood 

components, and blood products that 

have been approved by the Director of 

the Center for Biologics Evaluation and 

Research (CBER). Also, FDA is 

announcing that this list is posted on 

the Internet and it will be periodically 

updated.

ADDRESSES: Copies of the cumulative 

list of exceptions and alternative 

procedures are available from the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852, and the Office of 

Communication, Training and 

Manufacturers Assistance (HFM–40), 

Food and Drug Administration, suite 

200 N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 1–800–835–4709 or 

301–827–1800. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the cumulative list of 

exceptions and alternative procedures.

FOR FURTHER INFORMATION CONTACT:

Nathaniel L. Geary, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

The Director of CBER has approved 

exceptions or alternative procedures 

that have been requested by blood 

establishments under § 640.120 (21 CFR 

640.120). Section 640.120 grants the 

Director authority to approve exceptions 

or alternatives to any requirement in 

subchapter F (Biologics) of chapter I, 

parts 600 through 680 (21 CFR parts 600 

through 680) regarding blood, blood 

components, or blood products.

FDA is announcing publication of a 

cumulative list of exceptions and 

alternative procedures to requirements 

regarding blood, blood components, and 

blood products that have been approved 

by the Director of CBER. Also, FDA is 

announcing that this list is posted on 

the Internet and it will be periodically 

updated.

II. List of Approved Exceptions and 

Alternative Procedures (§ 640.120(b))

§ 600.15(a)

• Allow use of autologous units that 

were transported in a shipping 

container without ice and exposed to 

temperatures of 10.0 °C to 10.5 °C for 10 

minutes.

§ 606.60(b)

• Calibrate digital thermometer 

according to the schedule recommended 

by manufacturer, instead of monthly as 

required by regulation.

§ 606.65(e)

• Deviate from manufacturer’s 

instructions to use the Gen-Probe 

Procleix HIV–1/HCV Assay and Roche 

COBAS Ampliscreen HIV–1 and HCV 

nucleic acid tests on whole blood, red 

blood cells (RBC), platelets, source 

leukocytes, therapeutic exchange 

plasma, and recovered plasma intended 

for further manufacturing.

• Deviate from manufacturer’s 

instruction to use samples containing 

up to 200 milligrams (mg)/deciliters 

(dL) hemoglobin or 800 mg/dL 

triglycerides in the following assays: 

Abbott HIV AB HIV–1/HIV–2, (rDNA) 

EIA (LN3A77), Ortho Hepatitis B Core 

Antibody, Ortho Hepatitis B Surface 

Antigen ELISA System 2, and Roche 

Alanine Aminotransferase.

• Deviate from manufacturer’s 

instruction to use an alternate testing 

algorithm for confirming repeatedly 

reactive HIV–1 p24 antigen test results. 

Specifically, a licensed HIV–1 single 

unit Nucleic Acid Test will be 

performed in place of the HIV–1 p24 

antigen neutralization test and the 

results used for donor notification and 

counseling and recipient tracing.

• Deviate from manufacturer’s 

instructions to test donor specimens 

that were initially reactive using Ortho 

HbsAg System 3, in duplicate using 

Genetic Systems HbsAg EIA 3.0 (shaker 

method). If either or both of the donor 

samples test reactive using Genetic 

Systems HbsAg EIA 3.0 (shaker 

method), the donor specimen will be 

tested using Genetic Systems HbsAg 

Confirmatory 3.0 (shaker method).

§ 606.121

• Use of full face green labels for 

autologous use only units.

• Use of black print for all statements 

on container labels (omit use of 

statements in red print.) (Regulation 

revised—variance request no longer 

needed.)

• Use of ‘‘Autologous’’ on label in 

lieu of ‘‘Paid’’ or ‘‘Volunteer’’

• Omit special labeling from RBC 

with positive antibody screens that are 

suspended in additive solution, if the 

supernatant of the additive solution was 

tested using approved methods and 

found to be negative for unexpected 

antibodies.

• Place ABO/Rh label and ‘‘Donor 

Untested’’ on group and type label 

position.

• Print the anticoagulant name after 

the proper product name instead of 

preceding it. (Done for ISBT 128 labels.)

§ 606.122(m)

• Extend the storage time of thawed 

Fresh Frozen Plasma (FFP) at 1 to 6 °C 

to 24 hours, instead of 6 hours.

§ 606.151

• Omit performing a minor side 

crossmatch on RBC prepared in additive 

solutions that have not been screened 

for unexpected antibodies.

• Use of a computer (electronic) 

crossmatch instead of a major side 

crossmatch. (Regulation revised—

variance request no longer needed.)

• Use of a type and screen procedure 

as an alternative method for the 

antiglobulin crossmatch. (Regulation 

revised—variance request no longer 

needed.)

• Allow use of a recipient sample up 

to 72 hours old for pre-transfusion 

testing. (Regulation revised—variance 

request no longer needed.)

§ 610.40

• Ship source leukocytes to the 

manufacturer before infectious disease 

testing has been completed, provided 

the product is labeled that testing is not 

complete and stored in quarantine until 

the manufacturer has received the test 

results. (Regulation revised—variance 

request no longer needed.)

• Ship autologous blood unit to 

another establishment without testing 

unit for communicable disease agents. 

Testing performed on sample drawn on 

subsequent donation.

• Ship autologous blood unit to 

another establishment for processing 

and labeling and return to collecting 

facility without testing unit for 

communicable disease agents, provided 

neither facility has a crossover policy.

• Allow shipment under quarantine 

of untested source plasma labeled as 

57944 Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 

tested negative, to warehouse operated 

by another manufacturer for storage 

until testing is completed.

• Reinstate one donor with 

nondiscriminated results (NDR) on the 

Procleix HIV–1/HCV assay provided the 

donor tests negative for HIV RNA and 

HCV RNA using the Procleix 

Discriminatory assays and anti-HIV 1/2 

using Genetic Systems EIA.

• Allow shipment under quarantine 

of source plasma before completion of 

PCR testing, and labeled as pending 

NAT, to another licensed manufacturer 

who will cull and destroy NAT reactive 

units under a contractual arrangement 

with the source plasma manufacturer.

• Allow shipment under quarantine 

of source plasma that is labeled as 

negative/nonreactive for infectious 

diseases before completion of the 

infectious disease tests, to a contract offsite storage facility not operating under 

a U.S. license. source plasma 

manufacturer will cull and destroy 

reactive units according to their 

standard procedures.

§ 610.53

• Extend CPD and CP2D liquid 

plasma expiration date to 42 days when 

stored at 1 to 6 °C.

• Allow use of 53 vials of 

deglycerolized immunogen RBC that 

were exposed to temperatures from 6 to 

8 °C for up to 3 hours.

§ 640.3

• Allow whole blood collection from 

autologous donors who don’t meet 

donor suitability requirements.

• Allow whole blood collection from 

donors with a history of hepatitis before 

age 11. (Regulation revised—variance 

request no longer needed.)

• Allow 4-week intervals between 

FFP donations when it is collected as a 

by-product of a plateletpheresis 

procedure.

• Allow individuals with hereditary 

hemochromatosis to donate blood and 

blood components more frequently than 

every 8 weeks without examination or 

certification of health by physician at 

time of donation and to be exempt from 

placing special labeling about the 

donor’s disease on the blood 

components.

• Allow post-donation requalification 

after day of donation of donors who 

used an outdated vCJD donor 

questionnaire.

§§ 640.4(h) and 640.11(a)

• Allow use of whole blood and RBC 

that have been exposed to temperatures 

up to 11.5 °C for 4.5 hours or 17 °C for 

2 hours and 15 minutes, provided that 

the safety, purity, and potency were not 

affected.

§ 640.5

• Allow syphilis testing to be 

performed on 27 donors on a substitute 

sample drawn after day of donation.

• Allow specimens used for NAT 

assay to be collected up to 24 hours 

prior to the collection of heparinized 

whole blood units.

§ 640.11(a)

• Allow use of RBC and RBC 

Leukocyte-Reduced that were stored at 

1 °C to ¥3 °C for up to 4 hours, 

provided each unit was examined for 

hemolysis before distribution.

• Allow use of RBC that were exposed 

to temperatures between 6 °C and 10.5 

°C for up to 4.75 hours, provided each 

unit was examined for hemolysis before 

distribution.

§ 640.23(b)

• Allow ABO and Rh testing on 

plateletpheresis donors to be performed 

every 90 days.

§ 640.32(b)

• Relabel FFP collected by apheresis 

as recovered plasma prior to expiration 

of the original product. (Done to manage 

FFP inventory collected during periods 

of increased risk for West Nile Virus.)

§ 640.34

• Allow use of A and AB FFP that was 

warmed to ¥4 °C over an 18-hour time 

period, provided that safety, purity, and 

potency were not affected and the 

consignee is notified of the temperature 

deviation. Relabeling or shortening of 

the expiration date is not required.

• Allow plasma manufactured from 

whole blood to be frozen within 24 

hours after phlebotomy. Blood 

component must be labeled as 

‘‘PLASMA Frozen within 24 hours after 

Phlebotomy.’’

• Allow use of 45 units of FFP that 

were exposed to temperatures between 

-6 °C and ¥18 °C for a total of 4.5 hours, 

provided the blood components 

remained frozen during the whole time 

period.

• Allow distribution of 1,201 units of 

FFP and 395 units of Plasma 

Cryoprecipitate Reduced that were 

exposed to temperatures between -16.4 

°C and -18 °C for a total of 1.5 hours, 

provided the blood components 

remained frozen during the whole time 

period.

§§ 640.34 and 640.54(a)

• Allow distribution of 1,235 units of 

FFP and 963 units of Plasma 

Cryoprecipitate Reduced and prepare 

Cryoprecipitated AHF from 1,531 units 

Cryoprecipitate rich plasma that were 

exposed to temperatures between -11.8 

°C and -18 °C for a total of 5.5 hours, 

provided the blood components 

remained frozen during the whole time 

period.

§§ 640.61, 640.62, and 640.63

• Permit trained staff to explain the 

hazards of plasmapheresis and obtain 

informed consent.

• Allow physician substitutes to 

perform some of the duties of a 

physician (i.e., physical examinations of 

source plasma donors) and to approve 

physician substitute training programs.

§ 640.63

• Draw one donor with a rare RBC 

antibody who was Anti-HCV positive.

• Draw a donor with IgM Anti-HAV 

with a disease state program approval.

• Allow plasmapheresis of an 

asymptomatic donor with a history of 

Lyme Disease, provided product is 

labeled that it was collected from donor 

with a history of Lyme Disease.

• Allow a donor with a slightly 

abnormal Serum Protein Electrophoresis 

(SPE) to donate for an Infant Botulism 

Program.

• Allow individuals with childhood 

history of hepatitis at age 10 or younger 

to donate. (Regulation revised–variance 

request no longer needed.)

• Allow source plasma to be collected 

from a specific anti-e donor whose 

weight fluctuates between 108 and 112 

pounds (lbs) to donate, provided the 

weight does not drop below 108 lbs at 

time of donation and donor meets all 

other eligibility requirements.

§ 640.65

• Allow an infrequent plasmapheresis 

program in source plasma facilities. 

Donors may donate without a physical 

examination or SPE.

• Allow collection of source plasma 

from anti-HCV reactive donors with 

elevated SPE results (no more than 25 

percent over normal limits established 

by testing lab), provided the donor’s 

personal physician has given written 

approval.

§ 640.66

• Allow a physician substitute to 

schedule Tetanus Toxoid injections and 

review responses of donors immunized 

with licensed vaccines. The center 

physician must still do weekly 

evaluation of records.

§ 640.76

• Allow source plasma exposed to 

more than one episode of storage 

temperature fluctuations warmer than 

¥20 °C and colder than ¥5 °C for less 

than 72 total hours to not be relabeled 

as ‘‘Source Plasma, Salvaged,’’ provided 

the plasma was not allowed to thaw and 

the consignee is notified of the 

temperature deviations.

• Allow a revised procedure for 

labeling shipments of Source Plasma, 

Salvaged. Instead of labeling each unit, 

the facility may mark ‘‘Source Plasma, 

Salvaged’’ on the shipping cartons and 

packing slips.

• Allow 600 liters of source plasma 

stored at temperatures ranging from 

Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 57945

¥20 °C to +19 °C for 3 1/2 hours to be 

relabeled as ‘‘Source Plasma, Salvaged.’’

• Allow 53 units of source plasma 

intended for further manufacture into 

injectable products, that were stored at 

14 °C to be relabeled for further 

manufacture into noninjectable 

products, provided that label states that 

it was stored at 14 °C.

§§ 660.22 and 660.28

• Use FTA–ABS methodology as an 

alternative procedure to quantitative 

RPR testing on samples with a 

qualitative reactive RPR test for syphilis.

• Use an alternate procedure to 

perform FDA required tests for lot 

release action on bulk product prior to 

filling final containers for RBC antigen 

phenotyping reagents and Anti-Human 

Globulin reagents.

§ 660.28

• Allow the use of existing labels for 

blood grouping reagents, pending 

reprinting of corrected labels.

III. Electronic Access

Persons with access to the Internet 

may obtain the cumulative list of 

exceptions and alternative procedures at 

http://www.fda.gov/cber/blood/

exceptions.htm.

Dated: September 20, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21624 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, In Vivo 

Cellular and Molecular Imaging Centers 

(ICMICS). 

Date: November 4–5, 2004. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Kenneth L. Bielat, PhD, 

Scientific Review Administrator, Division of 

Extramural Activities, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, Room 7147, Bethesda, 

MD 20892, (301) 496–7576, 

bielatk@mail.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)

Dated: September 22, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–21710 Filed 9–27–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, NCI 

Review of Program Project Grant Application. 

Date: October 10–11, 2004. 

Time: 6 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: William D. Merritt, PhD, 

Scientific Review Administrator, Grants 

Review Branch, National Cancer Institute, 

National Institutes of Health, 6116 Executive 

Boulevard, Room 8034, MSC 8328, Bethesda, 

MD 20892–8328, 301–496–9767. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 22, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–21711 Filed 9–27–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Special Emphasis Panel, NCI 

Review of Program Project Grant Application. 

Date: October 12, 2004. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: William D. Merritt, PhD, 

Scientific Review Administrator, Grants 

Review Branch, National Cancer Institute, 

National Institutes of Health, 6116 Executive 

Boulevard, Room 8034, MSC 8328, Bethesda, 

MD 20892–8328, 301–496–9767. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer