[Federal Register: December 26, 2000 (Volume 65, Number 248)]
[Notices]
[Page 81528-81530]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de00-67]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1502]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Adverse Experience Reporting for Licensed
Biological Products, and General Records
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
January 25, 2001.
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:
Wendy Taylor, 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 collection of information to OMB for
review and clearance.
[[Page 81529]]
Adverse Experience Reporting for Licensed Biological Products; and
General Records--21 CFR 600.12 and Part 600 Subpart D (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
which 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 (AER)
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
AER 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 the AER 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 ensure the
manufacturer has taken adequate corrective action if necessary.
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 manufacturer 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.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of products
including 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.
Respondents to this information collection are manufacturers of
biological products. In fiscal year (FY) 99 there were approximately 79
licensed manufacturers. 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.
However, not all manufacturers may have any submissions in a given year
and some may have multiple submissions. FDA received four waiver
requests under Sec. 600.90, of which one was approved for exemption of
the AER requirements. In FY 99, there were an estimated 3,662 15-day
alert reports, 13,238 periodic reports, and 502 distribution reports
submitted to FDA. The number of 15-day alert reports 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 hours per response are based
on FDA experience. 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.
In the Federal Register of September 25, 2000 (65 FR 57612), the
agency requested comments on the proposed collection of information. No
significant comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR Annual Frequency Total Annual
Section No. of Respondents per Response Responses Hours per Response Total Hours
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600.80(c)(1 78 46.95 3,662 1 3,662
) and (e)
600.80(c)(2 78 169.72 13,238 1 13,238
)
600.81 78 6.4 502 1 502
600.90 4 1 4 1 4
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
There are approximately 343 licensed manufacturers of biological
products. However, the number of recordkeepers listed for
Sec. 600.12(a) through (e) excluding paragraph (b)(2) is estimated to
be 111. This number excludes
[[Page 81530]]
manufacturers of blood and blood components because their burden hours
for recordkeeping have been reported under Sec. 606.160 in OMB Control
No. 0910-0116. The recordkeeping burden is based on the number of lots
released (6,446), the number of recalls made (1,176), and the total
number of AER reports received (16,900) for FY 99. The hours per record
are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
Table 2.--Estimated Annual Recordkeeping Burden\1\
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21 CFR Annual Frequency Total Annual Hours per
Section No. of Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
600.12 111 58.1 6,446 32 206,272
600.12(b)(2 343 3.4 1,176 24 28,224
)
600.80(i) 79 213.92 16,900 1 16,900
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32783 Filed 12-22-00; 8:45 am]
BILLING CODE: 4160-01-S