[Federal Register Volume 60, Number 217 (Thursday, November 9, 1995)]
[Rules and Regulations]
[Pages 56514-56516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27714]
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[[Page 56515]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 429
[Docket No. 91N-0173]
RIN 0910-AA07
Fees for Certification of Drugs Composed Wholly or Partly of
Insulin
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule; opportunity for public comment.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an interim
final rule to amend its regulations establishing the fee schedule for
the insulin certification program. The interim final rule decreases the
fees charged for insulin certification services because experience has
demonstrated that the current fee schedule does not accurately reflect
FDA's actual cost of administering the insulin certification program.
DATES: The interim final rule is effective December 11, 1995, written
comments by February 7, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug
Evaluation and Research (HFD-362), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1049.
SUPPLEMENTARY INFORMATION:
I. Introduction
In 1941, Congress amended the Federal Food, Drug, and Cosmetic Act
(the act) to require FDA to certify batches of drugs composed wholly or
partly of insulin (Pub. L. 77-366). This amendment created section 506
of the act (21 U.S.C. 356), which requires the agency to provide for
the certification of a batch of a drug composed wholly or partly of
insulin if the ``drug has such characteristics of identity and such
batch has such characteristics of strength, quality, and purity [that
are] * * * necessary to adequately insure safety and efficacy of use *
* *.'' Section 506 of the act also requires FDA to promulgate
regulations governing the certification of drugs containing insulin.
Uncertified batches of insulin that are shipped in interstate commerce
are misbranded under section 502 of the act (21 U.S.C. 352) and are
subject to seizure and other sanctions under the act.
FDA's regulations providing for insulin certification are set forth
in part 429 (21 CFR part 429). These regulations include requirements
for packaging and labeling (Secs. 429.10 through 429.12), product
standards (Secs. 429.25 and 429.26), tests and methods of assay
(Sec. 429.30), and the contents of requests for certification and
samples required to be submitted (Sec. 429.40), as well as setting
forth the standards for review and approval of requests for
certifications (Sec. 429.41). In addition, insulin is considered to be
a new drug subject to section 505 of the act (21 U.S.C. 355).
Therefore, drug products containing insulin must have an approved new
drug application, submitted and approved under section 505 of the act
and 21 CFR part 314 of the regulations, to market the drug in
interstate commerce.
Under FDA's insulin certification program, insulin manufacturers
submit a ``Request for Certification of an Insulin Batch'' containing
manufacturing and analytical data, as well as product samples of the
master lot of insulin crystals and insulin finished dosage forms, to
FDA's Division of Prescription Drug Compliance and Surveillance and
FDA's insulin laboratory in the agency's Center for Drug Evaluation and
Research. The Division of Prescription Drug Compliance and Surveillance
reviews the incoming requests and determines which tests that FDA needs
to perform. After review of the analytical data, physical examination,
and completion of testing, FDA's insulin laboratory forwards its report
and recommendation to the Division of Prescription Drug Compliance and
Surveillance, where the data is reviewed and compared with the data
reported in the manufacturer's request for certification. If both
documents show that the batch conforms to the requisite standards of
identity, strength, quality, and purity, the agency issues an insulin
certificate.
II. Fee Schedule
Section 506(b)(5) of the act requires FDA to establish such fees as
are necessary to provide, equip, and maintain an adequate certification
service. These fees are intended to recover the full costs of operation
of FDA's insulin certification program. The current fee schedule set
forth in Sec. 429.55(b) was published as an interim final rule in the
Federal Register of October 4, 1991 (56 FR 50248). This interim final
rule revises those fees to more accurately reflect the cost of
maintaining the insulin certification program. FDA currently charges
$3,900 to certify each master lot and $2,800 to certify each dosage
form batch. Under the new fee schedule, FDA will charge $2,400 to
certify each master lot and $1,700 for each dosage form batch. All cost
estimates are described in detail in a September 1995 FDA study of the
insulin certification program's cost. A copy of the study has been
placed on file at the Dockets Management Branch (address above). A
provision of the current fee schedule allowing FDA to increase fees as
Government salaries increase has been retained, with minor changes to
emphasize the discretionary nature of any such fee increase. Fee
increases based on salary increases will not take place before January
1, 1997.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the interim final rule under
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The agency
believes that this interim final rule is consistent with the regulatory
philosophy and principles identified in the Executive Order. In
addition, the interim final rule is not a significant regulatory action
as defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA estimates that the fee schedule set out in this
interim final rule will result in a decrease of approximately $400,000
annually in fees collected by the agency, and will not result in any
increase in cost to manufacturers of drug products containing insulin.
The agency certifies that the interim final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
[[Page 56516]]
V. Effective Date and Opportunity for Public Comment
The agency is issuing this amendment as an interim final rule
effective December 11, 1995. The establishment of fees necessary to
provide, equip, and maintain an adequate certification program for
insulin has been mandated by Congress under section 506(b) of the act
(21 U.S.C. 356(b)). As certification services are provided to
manufacturers directly by FDA, the setting of a fee schedule to pay for
these services is a matter particularly within the purview and
expertise of the agency. The fees established by this regulation have
been based on cost accounting methods using data compiled by the
agency. The cost accounting methods used are the same as those used in
two previous rulemakings that established fees for insulin
certification. FDA invited comment on these rulemakings, but received
none addressing either the adequacy of the fees or accuracy of the cost
accounting methods used. Moreover, FDA's experience under the 1991 fee
schedule indicates that the fees in that fee schedule do exceed the
amounts needed to provide for the insulin certification program and
are, therefore, in excess of the fees authorized by the act. For the
foregoing reasons, FDA finds for good cause that notice and public
procedure would be unnecessary, and contrary to the public interest,
and, therefore, a public comment period before the establishment of
this rule may be dispensed with under 5 U.S.C. 553(b)(B).
FDA believes that it is appropriate to invite and consider public
comments on the provisions of this interim final rule, to determine if
these provisions should be amended in the future. Therefore, under 21
CFR 10.40(e), interested persons may, on or before February 7, 1996,
submit to the Dockets Management Branch (address above) written
comments regarding this document. FDA will use any comments received to
determine whether this interim final rule should be modified or other
administrative actions taken. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 429
Administrative practice and procedure, Drugs, Labeling, Packaging
and containers, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
429 is amended as follows:
PART 429--DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN
1. The authority citation for 21 CFR part 429 continues to read as
follows:
Authority: Secs. 502, 506, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352, 356, 371).
2. Section 429.55 is amended by revising paragraph (b) to read as
follows:
Sec. 429.55 Fees.
* * * * *
(b) The fees for requests for certification submitted under
Sec. 429.40 are as follows:
(1) $2,400 for each master lot or mixture of two or more master
lots or parts thereof.
(2) $1,700 for each dosage form batch.
(3) The fees established in this paragraph may increase as Federal
salary costs increase. The rate of increase will be no higher than
Federal salary increases, commencing with pay raises on or after
January 1, 1997. Notification of the exact fees established and
adjustments will be communicated directly to the manufacturers of
insulin products.
* * * * *
Dated: November 2, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-27714 Filed 11-8-95; 8:45 am]
BILLING CODE 4160-01-F