[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
