[Federal Register Volume 67, Number 195 (Tuesday, October 8, 2002)]
[Notices]
[Pages 62727-62729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0308]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 7, 2002.

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: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 62728]]

collection of information to OMB for review and clearance.

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 
current good manufacturing practices (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. In part 606 (21 CFR part 606), Sec.  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) 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 requires that legible and indelible 
contemporaneous records of each significant step be made and maintained 
for no less than 5 years. Section 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 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 CGMPs in 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 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. FDA estimates 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

[[Page 62729]]

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                Annual Frequency per   Total Annual     Hours per
     21 CFR Section       No. of Respondents         Response            Responses      Response     Total Hours
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606.170(b)\2\                    70                     1                    70            20        1,400
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610.46(a)                     1,041                    20                21,000             0.17     3,570
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610.46(b)                     1,041                    20                21,000             0.17     3,570
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610.47(b)                       166                     0.7                 116             1          116
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Total                     ..................  ......................  ..............  ............   8,656
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\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).


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                  No. of Record-   Annual Frequency per      Total Annual        Hours per
 21 CFR Section      keepers          Record-keeping            Records           Record          Total Hours
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606.100(b)\2\       249\5\                  1                   249                24             5,976
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606.100(c)          249\5\                 10                 2,490                 1             2,490
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606.110(a)\3\        67\6\                  5                   335                 0.5             168
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606.151(e)          249\5\                 12                 2,988                 0.083           248
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606.160\4\          249\5\              2,169               540,000                 0.5         270,000
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606.165             249\5\              2,169               540,000                 0.083        44,820
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606.170(a)          249\5\                 12                 2,988                 1             2,988
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Total            ...............  ......................  ..................  ..............    326,690
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The recordkeeping requirements in Sec.  Sec.   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 Sec.  Sec.   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\ 5 percent of CMS and FDA-registered blood establishments (0.05 x 4,890).
\6\ 5 percent of pheresis establishments (1,349).


    Dated: October 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25539 Filed 10-7-02; 8:45 am]
BILLING CODE 4160-01-S