[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