[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22401-22404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0231]
Agency Information Collection Activities; Proposed Collection;
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 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 proposed extension of the
collection of information concerning requirements relating to FDA's
adverse experience reporting (AER) for licensed biological products,
and general records associated with the manufacture and distribution of
biological products.
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DATES: Submit either written or electronic comments on the collection
of information by June 20, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@
fda.hhs.gov.
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 these topics: (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; and
General Records--21 CFR Part 600 (OMB Control Number 0910-0308)--
Extension
Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to insure its safe use. FDA issued the AER
requirements in part 600 (21 CFR part 600) 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 identify
potentially serious safety problems with licensed biological products.
Although premarket testing discloses a general safety profile of a
biological product'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. In addition, production and/or
distribution problems have contaminated biological products in the
past. AER reports are obtained from a variety of sources, including
manufacturers, patients, physicians, foreign regulatory agencies, and
clinical investigators. Identification of new and unexpected safety
issues through the analysis of the data in the AERS system contributes
directly to increased public health protection. For example, evaluation
of these safety issues enables FDA to take focused regulatory action.
Such action may include, but is not limited to, important changes to
the product's labeling (such as adding a new warning), coordination
with manufacturers to ensure adequate corrective action is taken, and
removal of a biological product from the market when necessary.
Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires a
person who submits an adverse action report to the licensed
manufacturer rather than FDA to maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually since a large
percentage of currently licensed biological products have been licensed
longer than 3 years. Section 600.80(i) requires 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
requires licensed manufacturers to submit, at an interval of every 6
months, information about the quantity of the product distributed under
the biologics license, including the quantity distributed to
distributors. These distribution reports provide FDA with important
information about products distributed under biologics licenses,
including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., fifty thousand per 10-
milliliter vials), and date of release. FDA may require the licensed
manufacturer to submit distribution reports under this section at times
other than every 6 months. Under Sec. 600.90, a licensed manufacturer
may submit a waiver request for any requirements that apply to the
licensed manufacturer under Sec. Sec. 600.80 and 600.81. A waiver
request submitted under Sec. 600.90 must include supporting
documentation.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product
including any
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recalls. These recordkeeping requirements serve preventative and
remedial purposes by establishing accountability and traceability in
the manufacture and distribution of products. These requirements also
enable FDA to perform meaningful inspections. Section 600.12 requires,
among other things, that records must be made, concurrently with the
performance of each step in the manufacture and distribution of
products. These records must be 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, under Sec. 600.12, manufacturers must
maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec. 610.18(b) requires, in part, that the results of all
periodic tests for verification of cultures and determination of
freedom from extraneous organisms be recorded and maintained.
Respondents to this collection of information include manufacturers
of biological products and any person whose name appears on the label
of a licensed biological product. Under table 1 of this document, the
number of respondents is based on the estimated number of manufacturers
that are subject to those regulations or that submitted the required
information to the Center for Biologics Evaluation and Research and
Center for Drugs Evaluation and Research, FDA, in fiscal year (FY)
2010. Based on information obtained from the FDA's database system,
there were 108 licensed biologics manufacturers. This number excludes
those manufacturers who produce Whole Blood or components of Whole
Blood and in-vitro diagnostic licensed products, because of the
exemption under Sec. 600.80(k). The total annual responses are based
on the number of submissions received by FDA in FY 2010. There were an
estimated 86,583 15-day Alert reports, 57,300 periodic reports, and 349
lot distribution reports submitted to FDA. The number of 15-day alert
reports for postmarketing studies under Sec. 600.80(e) is included in
the total number of 15-day alert reports. FDA received 21 requests for
waivers under Sec. 600.90, of which 19 were granted. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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600.80(c)(1) and 600.80(e)...... 108 801.69 86,583 1 86,583
600.80(c)(2).................... 108 530.55 57,300 28 1,604,400
600.81.......................... 108 3.23 349 1 349
600.90.......................... 21 1 21 1 21
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Total....................... .............. .............. .............. .............. 1,691,353
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Under table 2 of this document, the number of respondents is based
on the number of manufacturers subject to those regulations. Based on
information obtained from FDA's database system, there were 304
licensed manufacturers of biological products in FY 2010. However, the
number of recordkeepers listed for Sec. 600.12(a) through (e)
excluding (b)(2) is estimated to be 131. This number excludes
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 total annual records is based on the annual average
of lots released in FY 2010 (6,752), number of recalls made (1,881),
and total number of adverse experience reports received (143,883) in FY
2010. 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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Average burden
Number of Number of Total annual per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
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600.12 \2\...................... 131 51.54 6,752 32 216,064
600.12 (b)(2)................... 304 6.19 1,881 24 45,144
600.80(c)(1) and 600.80(i)...... 108 1,332.25 143,883 1 143,883
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Total....................... .............. .............. .............. .............. 405,091
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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. 610.18(b) are included in the estimate for Sec. 600.12.
[[Page 22404]]
Dated: April 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9651 Filed 4-20-11; 8:45 am]
BILLING CODE 4160-01-P