[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37394-37396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0482]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 information collection 
provisions relating to the regulation of FDA's adverse experience 
reporting (AER) for licensed biological products and general records.

DATES: Submit written comments on the collections of information by 
September 8, 1998.

ADDRESSES: Submit written comments on the collections of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collections 
of information listed below.
    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.

Adverse Experience Reporting for Licensed Biological Products--21 
CFR 600.80, 600.81, and 600.90; and General Records--21 CFR 600.12 
(OMB Control Number 0910-0308)--Extension

    Under the Public Health Service Act (42 U.S.C. 262), FDA is 
required to ensure the marketing of only those biological products that 
are safe and effective. FDA must therefore be informed of all adverse 
experiences occasioned by the use of licensed biological products. FDA 
issued the adverse experience reporting requirements to enable FDA to 
take actions necessary for the protection of the public health in 
response to reports of adverse experiences related to licensed 
biological products. The primary purpose of FDA's adverse experience 
reporting system is to flag potentially serious safety problems with 
licensed biological products, focusing especially on newly licensed 
products. Although premarket testing discloses a general safety profile 
of a new drug's comparatively common adverse effects, the larger and 
more diverse patient populations exposed to the licensed biological 
product provides the opportunity to collect information on rare, 
latent, and long-term effects. Reports are obtained from a variety of 
sources, including patients, physicians, foreign regulatory agencies, 
and clinical investigators. Information derived from

[[Page 37395]]

the adverse experience reporting system contributes directly to 
increased public health protection because such information enables FDA 
to recommend important changes to the product's labeling (such as 
adding a new warning), to initiate removal of a biological product from 
the market when necessary, and to assure the manufacturer has taken 
adequate corrective action if necessary.
    Manufacturers of biological products for human use must also keep 
records of each step in the manufacture and distribution of products 
including any recalls of the product. The recordkeeping requirements 
serve preventative and remedial purposes. These requirements establish 
accountability and traceability in the manufacture and distribution of 
products, and enable FDA to perform meaningful inspections.
    Section 600.12 (21 CFR 600.12) requires that all records of each 
step in the manufacture and distribution of a product be made and 
retained for no less than 5 years after the records of manufacture have 
been completed or 6 months after the latest expiration date for the 
individual product, whichever represents a later date. In addition, 
records of sterilization of equipment and supplies, animal necropsy 
records, and records in cases of divided manufacturing of a product are 
required to be maintained. Section 600.12(b)(2) requires complete 
records to be maintained pertaining to the recall from distribution of 
any product.
    Section 600.80(c)(1) (21 CFR 600.80(c)(1)) requires the licensed 
manufacturer to report each adverse experience that is both serious and 
unexpected, regardless of source, as soon as possible but in any case 
within 15 working days of initial receipt of the information. Section 
600.80(e) requires licensed manufacturers to submit a 15-day alert 
report obtained from a postmarketing clinical study only if there is a 
reasonable possibility that the product caused the adverse experience. 
Section 600.80(c)(2) requires the licensed manufacturer to report each 
adverse experience not reported under paragraph (c)(1) at quarterly 
intervals, for 3 years from the date of issuance of the product 
license, and then at annual intervals. The majority of the periodic 
reports will be submitted annually since a large percentage of the 
current licensed biological products have been licensed longer than 3 
years. Section 600.80(i) requires the licensed manufacturers to 
maintain for a period of 10 years records of all adverse experiences 
known to the licensed manufacturer, including raw data and any 
correspondence relating to the adverse experiences. Section 600.81 (21 
CFR 600.81) requires the licensed manufacturer to submit information 
about the quantity of the product distributed under the product 
license, including the quantity distributed to distributors at an 
interval of every 6 months. The semiannual distribution report informs 
FDA of the quantity, the lot number, and the dosage of different 
products. Section 600.90 (21 CFR 600.90) requires a licensed 
manufacturer to submit a waiver request with supporting documentation 
when asking for waiving the requirement that applies to them under 
Secs. 600.80 and 600.81.
    Respondents to this collection of information are manufacturers of 
biological products. In fiscal year (FY) 1996, there were approximately 
72 licensed manufacturers, 3 of which submitted waiver requests under 
Sec. 600.90 and were exempt from these AER requirements. This number 
excludes those manufacturers who produce blood and blood components and 
in vitro diagnostic licensed products because they are specifically 
exempt from the regulations. In FY 1996, there were 1,616 15-day alert 
reports, 5,903 periodic reports and 464 distribution reports submitted 
to FDA. The number of 15-day alert report for postmarketing studies as 
stated in Sec. 600.80(e) was minimal and is included in the total 
number of 15-day alert reports. The burden hours required to complete 
the MedWatch Form for Sec. 600.80(c)(1), (e), and (f) are reported 
under OMB Control No. 0910-0291. FDA estimates the burden of this 
collection of information as follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                     Number of                                                  
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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600.80(c)(1) and 600.80(e)             69              23.4         1,616               1           1,616       
600.80(c)(2)                           69              85.6         5,903               1           5,903       
600.81                                 69               6.7           464               1             464       
600.90                                  3               1               3               1               3       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    There are approximately 391 licensed manufacturers of biological 
products. However, the number of recordkeepers listed for 
Sec. 600.12(a) through (e) excluding (b)(2) is estimated to be 102. 
This number excludes manufacturers of blood and blood components 
because their burden hours for recordkeeping have been reported under 
21 CFR 606.160 in OMB Control No. 0910-0116. The recordkeeping burden 
is based on the number of lots released (9,027), the number of recalls 
made (710) and the total number of AER reports received (7,519) for FY 
1996. FDA estimates that the average time associated with recordkeeping 
per lot is 32 hours, for recalls is 24 hours, and for adverse 
experience reports is 1 hour. FDA estimates the burden of this 
recordkeeping as follows:

                                Table 2.--Estimated Annual Recordkeeping Burden1                                
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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600.12                                102              88.5         9,027           2,832         288,864       
600.12(b)(2)                          391               1.8           710              43          16,813       
600.80(i)                              69             109           7,519             109           7,519       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 37396]]

    Dated: June 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18402 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F