[Federal Register Volume 63, Number 203 (Wednesday, October 21, 1998)]
[Notices]
[Pages 56192-56195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0143]


Agency Emergency Processing Request Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns procedures recommended in a guidance entitled 
``Guidance for Industry: Current Good Manufacturing Practice for Blood 
and Blood Components: (1) Quarantine and Disposition of Units From 
Prior Collections From Donors With Repeatedly Reactive Screening Test 
for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, 
and the Notification of Consignees and Blood Recipients of Donor Test 
Results for Anti-HCV.''

DATES: Submit written comments on the collection of information by 
November 2, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: With respect to the following collection of 
information, FDA invites comments on: (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.

Guidance for Industry: Current Good Manufacturing Practice for 
Blood and Blood Components: (1) Quarantine and Disposition of Units 
From Prior Collections From Donors With Repeatedly Reactive 
Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) 
Supplemental Testing, and the Notification of Consignees and Blood 
Recipients of Donor Test Results for Anti-HCV

    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a guidance entitled ``Guidance for Industry: 
Current Good Manufacturing Practice for Blood and Blood Components: (1) 
Quarantine and

[[Page 56193]]

Disposition of Units From Prior Collections From Donors With Repeatedly 
Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); 
(2) Supplemental Testing, and the Notification of Consignees and Blood 
Recipients of Donor Test Results for Anti-HCV.'' The guidance document 
provides recommendations for donor screening and supplemental testing 
for antibody to HCV, quarantine of prior collections from a donor who 
later tests repeatedly reactive for antibody to HCV, and notification 
and counseling of recipients of blood and blood components at increased 
risk for transmitting HCV. The statutory authority to collect this 
information is provided under sections 351 and 361 of the Public Health 
Service Act (the PHS Act) (42 U.S.C. 262 and 264) and the provisions of 
the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 
201 et seq.). The purpose of this guidance is to help ensure the 
continued safety of the blood supply by preventing the introduction, 
transmission, and spread of HCV. The collection of information 
described in the guidance will help ensure that important information 
is provided to consignees and recipients of blood and blood components 
from a donor who later tests positive for HCV. Also, the collection of 
information will enable consignees to identify and quarantine product 
that may be at increased risk for transmitting HCV. As a result, 
transfusion recipients of such product may have the opportunity to seek 
medical counseling.
    Lookback (product retrieval and recipient notification) related to 
hepatitis B virus (HBV), HCV, and human T-lymphotropic virus (HTLV-I) 
testing has been discussed at open public meetings, including meetings 
of FDA's Blood Products Advisory Committee, on multiple occasions since 
October 1989. As a response to these discussions, FDA provided detailed 
guidance in the July 19, 1996, memorandum on the quarantine and 
disposition of certain prior collections of blood and blood components 
from donors who subsequently test repeatedly reactive for hepatitis B 
surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-
HBc), anti-HCV, or antibody to HTLV type I (anti-HTLV-I). The 
memorandum recommended that blood establishments notify consignees 
(such as the transfusion service, physician, fractionator, etc.) for 
the purpose of quarantine and eventual disposition of products made 
from prior collections. At that time, FDA did not recommend 
notification of recipients of blood from donors who subsequently test 
positive for anti-HCV, because no clear consensus on the public health 
benefit of such action had emerged.
    Improvements in the treatment and management of HCV infections have 
occurred recently, and at public meetings on April 24 and 25, 1997, and 
August 11 and 12, 1997, the PHS Advisory Committee on Blood Safety and 
Availability discussed recipient notification related to hepatitis C. 
Consistent with recommendations of the Public Health Service Advisory 
Committee, in the Federal Register of March 20, 1998 (63 FR 13675), FDA 
issued a guidance regarding such notification for implementation and 
comment. In response to comments received, FDA is now issuing the 
previously referenced guidance, which supersedes the guidance issued on 
July 19, 1996, and replaces the guidance issued on March 20, 1998.
    Description: This guidance recommends that blood establishments 
prepare and follow written procedures when blood establishments have 
collected Whole Blood, blood components, Source Plasma, and Source 
Leukocytes later determined to be at risk for transmitting HCV 
infections. This guidance provides recommendations, similar to the 
requirements now in effect for HIV ``Lookback'' (21 CFR 610.46 and 
610.47), to clarify the status of the donor who later tests repeatedly 
reactive for HCV, to quarantine prior collections from such donors, and 
to notify transfusion recipients, as appropriate, based on further 
testing of the donor. The guidance recommends that when a donor who 
previously donated blood is tested in accordance with this guidance on 
a later donation, and tests repeatedly reactive for antibody to HCV, 
the blood establishment should perform a supplemental test using a 
licensed test, and notify consignees who received Whole Blood, blood 
components, Source Plasma, and Source Leukocytes from prior collections 
so that appropriate action is taken. The guidance document recommends 
that blood establishments and consignees quarantine previously 
collected Whole Blood, blood components, Source Plasma and Source 
Leukocytes from such donors, and if appropriate, consignees should 
notify transfusion recipients. In addition to the prospective 
``lookback'' recommendations that are similar to the ``lookback'' 
requirements for HIV, this guidance recommends a retrospective review 
of testing records that should identify prior collections from donors 
at increased risk for transmitting HCV as far back as 10 years. Under 
this guidance, it is suggested that blood establishments notify 
consignees of the risk of HCV transmission that exists for prior 
collections based on the retrospective review of record and the results 
of the supplemental testing performed before or as a result of the 
retrospective review of records. In addition, the guidance recommends 
that blood establishments notify consignees of the risk of HCV 
transmission that exists for prior collections from a donor who tested 
repeatedly reactive on a screening test for HCV and has no record of 
further testing and now cannot be clarified because further testing is 
impractical or infeasible. This guidance recommends that blood 
establishments maintain records of the source and disposition of all 
units of blood and blood products for at least 10 years from the date 
of disposition or 6 months after the latest product expiration date, 
whichever is the later date. Under 21 CFR 606.160, such records are 
required to be retained for 5 years. FDA is recommending an extended 
records retention period because advances in medical diagnosis and 
therapy have created opportunities for disease prevention or treatment 
many years after recipient exposure to a donor later determined to be 
at increased risk for transfusion-transmitted disease. Additionally, 
methods of recordkeeping have advanced, improving the ability of blood 
establishments to more easily maintain and retrieve records. Also, this 
guidance recommends that any consignee of a blood establishment notify 
the transfusion recipients of blood and blood components at increased 
risk for transmitting HCV.
    The agency is issuing this guidance to promote the continued safety 
of the blood supply, to help provide users with critical information 
about blood and blood components, and to promote notification to 
transfusion recipients regarding receipt of blood and blood components 
at risk for transmitting HCV.
    Description of Respondents: Blood establishments (Business and Not-
for-Profit) and consignees of blood establishments, including 
hospitals, transfusion services, and physicians.
    The total reporting and recordkeeping burden is estimated to be 
285,867 hours. However, of this total approximately 268,374 hours would 
be expended on a one-time basis for establishing the written procedures 
and doing the one-time retrospective review of records. Therefore, 
17,493 hours is estimated as the ongoing annual burden related to this 
guidance. The total ongoing

[[Page 56194]]

prospective annual burden for blood establishments is estimated to be 
12,630 hours. The prospective annual burden for consignees of blood 
establishments is estimated to be 4,863 hours.
    The burden estimates are based on Health Care Financing 
Administration (HCFA) and FDA registration records and the following 
estimates from the Centers for Disease Control and Prevention (CDC). 
CDC estimates there are approximately 9,750,127 donations from repeat 
donors per year and the prevalence of HCV among donors is 0.27 percent. 
Therefore, CDC estimates that 26,325 repeat donors per year could test 
repeatedly reactive for HCV. For each of these donors, the 
recommendations in this guidance call for blood establishments to 
notify the consignee (transfusion service) two times (once for 
quarantine purposes and again with supplemental test results) for a 
total 52,650 notifications as an annual ongoing burden. Based on 
estimates from CDC, FDA expects that for the one-time review of 
records, as many as 237,688 blood products would be at increased risk 
for transmitting HCV. Therefore, FDA estimates that for each of these 
products, blood establishments should notify consignees to quarantine 
these products, should report supplemental test results to consignees, 
and consignees should notify recipients or the recipients' attending 
physician. The guidance recommends that blood establishments notify the 
consignees two times (once for quarantine purposes and again with 
supplemental test results) for a total of 475,376 notifications as a 
result of the retrospective review. The total annual responses for 
blood establishments is estimated to be the combined number of 
notifications (475,376 + 52,650) or 528,026. FDA estimates the amount 
of time for each notification of a consignee by a blood establishment 
will be approximately 12 minutes (0.2 hours). Consequently, the total 
estimated reporting burden hours for blood establishments is (528,026 
report notifications x 0.2 hrs) 105,605 hours. However, the ongoing 
annual burden not associated with the retrospective review would be 
10,530 hours (52,650 x 0.2 hours).
    CDC expects that approximately 2,730 repeat donors who have 
repeatedly reactive HCV screening test results will confirm positive 
for HCV each year. Based on CDC's research and information, a donor who 
confirms positive for HCV will have donated on the average only two 
previous times and on the average only 1.6 components will have been 
made from each donation. Based on this information, there could be 
8,736 transfusion recipients that should be notified per year (2,730 
repeat donors per year that confirm positive for HCV x 2 prior 
donations per donor x 1.6 components per donation). Thus, the total 
notifications by consignees is estimated to be 246,424 annually (8,736 
transfusion recipients who may be at increased risk of transmitting HCV 
plus the estimated 237,688 transfusion recipients identified from a 
retrospective review). The time estimated for consignees to make a 
notification is 30 minutes or 0.5 hours on average. This time, which is 
somewhat longer than for blood establishments to notify consignees, 
allows for the possibility of having to make up to three attempts to 
complete the notification process and creates a total reporting burden 
of 123,212 hours. However, the ongoing annual reporting burden for 
consignees is expected to be only 4,368 hours (8,736 recipients per 
year x 0.5 hours). According to the HCFA, there are approximately 6,200 
consignees that should be responsible for notification.
    In the recordkeeping Table 2 of this document, the 8.75 hours per 
blood establishment recordkeeper represents 8 hours to develop written 
procedures for the HCV lookback recommendations and 0.75 hours to 
update 9 HCV repeat reactive records (frequency of recordkeeping is 10 
less 1 written procedure = 9 HCV testing records on average). FDA 
estimates that it takes approximately 5 minutes to update each record 
(9 x 5 minutes = 45 minutes or 0.75 hours per recordkeeper). Therefore, 
the total recordkeeping by blood establishments is estimated to be 
24,500 hours. Likewise, the 5.25 hours per consignee recordkeeper 
includes 2 hours to develop written procedures for the HCV lookback 
notification process and 3.25 hours to update 39 transfusion recipient 
records (frequency of consignee recordkeeping is 40 less 1 written 
procedure = 39 recipient records on average). FDA estimates that it 
takes approximately 5 minutes to update each record (39 x 5 minutes = 
195 minutes or 3.25 hours). Therefore, the total recordkeeping burden 
for consignees is estimated to be 32,550. The combined total 
recordkeeping burden for both blood establishments and consignees is 
estimated to be 57,050 hours. However, based on the prospective number 
of repeat donors per year and the number that confirm positive for HCV, 
the ongoing annual recordkeeping burden may only be 2,596 hours. Over 
time we expect the ongoing annual recordkeeping burden to decline much 
as the prevalence of HCV among donors has declined due to the 
implementation of screening tests for anti-HCV which helps to reduce 
the number of donors infected with HCV from the donor pool.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
       Collection Activity            No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Blood Establishments                2,800              38         528,026                .2       105,605
Consignees                          6,200              40         246,424                .5       123,212
Total                                                                                             228,817
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
       Collection Activity            No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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Blood Establishments                2,800              10          29,125               8.75       24,500
Consignees                          6,200              40         252,624               5.25       32,550

[[Page 56195]]

Total                                                                                              57,050
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Maintenance costs were not estimated for the additional maintenance 
of records beyond the current 5 years to the recommended 10 years, 
because modern storage technology has markedly reduced the space needed 
to store records.
    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA and 5 CFR 1320.13. 
Because HCV frequently causes chronic infection of the liver, it can 
cause serious liver injury and can be life threatening, and because new 
therapies are recently available, it is essential to the agency's 
mission of protecting and promoting the public health that this 
guidance be made available to the public immediately. The information 
is needed immediately to replace the March 20, 1998, guidance that was 
withdrawn September 8, 1998. The use of normal clearance procedures 
could take 180 days or more, during which time guidance would not be in 
place, thus disrupting or preventing this collection of information.

    Dated: October 14, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-28218 Filed 10-20-98; 8:45 am]
BILLING CODE 4160-01-F