[Federal Register Volume 65, Number 181 (Monday, September 18, 2000)]
[Notices]
[Pages 56314-56315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1489]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Sterility Requirements for Aqueous-Based Drug Products 
for Oral Inhalation

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, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the reporting and recordkeeping 
requirements associated with sterility requirements for aqueous-based 
drug products for oral inhalation.

DATES: Submit written or electronic comments on the collection of 
information by November 17, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at http://www.accessdata.fda.gov/scripts/oc/edockethome.cfm. Submit written comments on the collection 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:  Karen L. Nelson, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

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: (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.

Sterility Requirements for Aqueous-Based Drug Products for Oral 
Inhalation (formerly known and approved under Sterility 
Requirements for Inhalation Solution Products) (OMB Control No. 
0910-0353)

    Sections 314.70(b) and 314.97 (21 CFR 314.70(b) and 314.97) require 
that all aqueous-based drug products for oral inhalation, including 
those currently approved, be manufactured sterile. Respondents will be 
required to submit a supplemental application under Sec. 314.70(b) or 
Sec. 314.97, describing their new manufacturing process for achieving 
sterility of their aqueous-based drug products for oral inhalation. FDA 
needs this information to determine compliance with this new regulation 
and will use information collected to make decisions on approval of 
supplemental applications.
    Based on new information collected by its contractor, ERG, FDA has 
revised its estimate of the number of respondents in the original 
proposal for reporting and recordkeeping burden. Because the 
respondents have changed, the estimate of the total hours have changed. 
In the proposed rule it was estimated that there were 5 manufacturers, 
while the final rule estimates there are 8 manufacturers with 11 
nonsterile products based on new data collected by ERG. However, four 
of the manufacturers are projected to cease manufacturing, leaving four 
companies manufacturing seven products. These companies are projected 
to cease manufacturing because they may lack the in-house technical 
capability to convert their operations or might find the prospective 
investments in sterile production technologies to be unattractive. 
Because each nonsterile product will require an annual report (21 CFR 
314.81(b)(2)(iv)), the number of annual responses for nonsterile 
products has increased to seven. Based on a review of FDA's past 
experience with applicants submitting supplemental applications under 
Sec. 314.97, we estimate 160 hours to prepare a supplemental 
application. Therefore, due to the increased estimate of respondents, 
the total hours for the annual reporting burden for manufacturers of 
nonsterile products has increased from 800 hours in the proposed rule 
to 1,120 hours in the final rule. The agency's review of the estimated 
reporting burden for manufacturers of sterile products in the proposed 
rule and its experience with the annual reporting burden for 
manufacturers of sterile products supported the estimate provided in 
the proposed rule. Therefore, the estimated reporting burden for 
manufacturers of sterile products is the same as in the proposed rule.
    Respondents to this information collection are businesses engaged 
in the manufacture of aqueous-based drug products for oral inhalation.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 56315]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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314.97                                  7               1               7             160         1,120\2\
314.70                                  2               1               1              20           40\3\
Total                                                                                               1,160
 
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Reporting burden for manufacturers of nonsterile products.
\3\ Reporting burden for manufacturers of sterile products.

    Because of the estimated increase from the proposed rule to the 
final rule in the number of respondents for nonsterile products, the 
number of recordkeepers in the recordkeeping burden of Table 2 has 
increased by two from the proposed rule. FDA estimated a total of seven 
recordkeepers in the proposed rule and now estimates a total of nine 
recordkeepers as a result of new data collected by ERG. The proposed 
rule estimated 2 hours per record, and FDA's review of that estimate 
and its experience with the control and validation of microbiological 
contamination supports this proposed estimate. Therefore, the total 
number of hours for the recordkeeping burden has increased from 14 
hours to 18 hours.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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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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211.113(b)                              9               1               9               2              18
Total                                                                                                  18
 
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 12, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23890 Filed 9-15-00; 8:45 am]
BILLING CODE 4160-01-F