[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Notices]
[Pages 47816-47818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0308]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practices and Related 
Regulations for Blood and Blood Components; and ``Lookback'' 
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements relating to the regulations of FDA's current good 
manufacturing practices (CGMP) and related regulations for blood and 
blood components, and ``lookback'' requirements.

DATES: Submit written or electronic comments on the collection of 
information by September 20, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    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.

Current Good Manufacturing Practices and Related Regulations for Blood 
and Blood Components; and ``Lookback'' Requirements (OMB Control Number 
0910-0116)--Extension

    Under the statutory requirements contained in section 351 of the 
Public Health Service 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 to 361 of the 
Public Health Service Act (42 U.S.C. 262 to 264) and the general 
administrative provisions under sections 501 to 503, 505 to 510, and 
701 to 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
to 353, 355 to 360, and 371 to 374), FDA has the authority to issue 
regulations designed to protect the public from unsafe or ineffective 
biological products and to issue regulations necessary to prevent the 
introduction, transmission, or spread communicable diseases. The CGMP 
and related regulations implement FDA's statutory authority to ensure 
the safety, purity, and potency of blood and blood components. The 
lookback regulations 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 at increased risk for transmitting human 
immunodeficiency virus (HIV) infection.
    The information collection requirements in the CGMP 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 perform 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.

[[Page 47817]]

    Section 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) 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 plasmapheresis of 
donors who do not meet donor requirements. 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, Sec. 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 606.165 (21 CFR 606.165) 
requires that distribution and receipt records be maintained to 
facilitate recalls, if necessary. Section 606.170(a) (21 CFR 
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 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 610.46(a) (21 CFR 610.46(a)) requires blood establishments to 
notify consignees, within 72 hours, of repeatedly reactive tests 
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's repeatedly 
reactive test. Section 610.47(b) (21 CFR 610.47(b)) requires 
transfusion services not subject to 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. In addition to the CGMP's in 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); 640.4(a); 640.25(b)(4) and (c)(1); 640.27(b); 
640.31(b); 640.33(b); 640.51(b); 640.53(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 21 CFR part 606 burden estimates, as described below.
    Respondents to this collection of information are licensed and 
unlicensed blood establishments inspected by FDA, and other transfusion 
services inspected by CMS.
    Based on FDA's registration system, there are approximately 2,841 
registered blood establishments inspected by FDA. Of these 2,841 
establishments, approximately 1,349 perform pheresis, approximately 
1,041 annually collect 27 million units of Whole Blood, blood 
components including Source Plasma, and Source Leukocytes and are 
required to follow FDA ``lookback'' procedures, and approximately 166 
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.
    The following reporting and recordkeeping estimates are based on 
information provided by industry, CMS, and FDA experience. In table 1 
of this document, we estimate that there are approximately 3,500 repeat 
donors that will test reactive on a screening test for HIV. We estimate 
that each repeat donor has donated two previous times and an average of 
three components were made from each donation. Under Sec. 610.46(a) and 
(b), this estimate results in 21,000 (3,500 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 21,000 (3,500 x 2 x 3) notifications to 
consignees of subsequent test results. Under Sec. 606.110(b), licensed 
establishments submit supplements to their biologics license 
applications to request prior CBER approval of plasmapheresis donors 
who do not meet donor requirements. The information collection 
requirements for Sec. 606.110(b) are reported under OMB control number 
0910-0338.
    In table 2 of this document, the recordkeeping chart reflects the 
estimate that 95 percent of the recordkeepers, which collect 98 percent 
of the blood supply, had developed SOP's as part of their customary and 
usual business practice. Establishments may minimize burdens associated 
with CGMP and related regulations by using model SOP's developed by 
industries' accreditation organizations. These accreditation 
organizations represent almost all registered blood establishments.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
                                    Annual
                        No. of    Frequency    Total      Hours    Total
   21 CFR Section    Respondents     per       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
606.170(b)\2\              70           1         70        20    1,400
610.46(a)               1,041          20     21,000      0.17    3,570
610.46(b)               1,041          20     21,000      0.17    3,570
610.47(b)                 166         0.7        116         1      116
Total                                                             8,656
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.
\2\The reporting requirement in Sec.  640.73, which addresses the
  reporting of fatal donor reactions, is included in the estimate for
  Sec.  606.170(b).


[[Page 47818]]


           Table 2.--Estimated Annual Recordkeeping Burden\1\
------------------------------------------------------------------------
                                      Annual      Total    Hours
  21 CFR Section       No. of     Frequency per   Annual    per    Total
                   Recordkeepers  Recordkeeping  Records  Record   Hours
------------------------------------------------------------------------
606.100(b)\2\         249\5\              1         249      24   5,976
606.100(c)            249\5\             10       2,490       1   2,490
606.110(a)\3\          67\6\              5         335     0.5     168
606.151(e)            249\5\             12       2,988   0.083     248
606.160\4\            249\5\          2,169      540,000    0.5   270,00
                                                                      0
606.165               249\5\          2,169      540,000  0.083   44,820
606.170(a)            249\5\             12       2,988       1   2,988
Total                                                             326,69
                                                                      0
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.
\2\The recordkeeping requirements in Secs.  640.3(a)(1), 640.4(a)(1),
  and 640.66, which address the maintenance of SOPs, are included in the
  estimate for Sec.  606.100(b).
\3\The recordkeeping requirements in Sec.  640.27(b), which address the
  maintenance of donor health records for the plateletpheresis, are
  included in the estimate for Sec.  606.110(a).
\4\The recordkeeping requirements in Secs.  640.3(a)(2); 640.3(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 (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 Sec.  606.160.
\5\Five percent of CMS and FDA-registered blood establishments (0.05 x
  4,890).
\6\Five percent of pheresis establishments (1,349).


    Dated: July 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18320 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S