[Federal Register Volume 66, Number 2 (Wednesday, January 3, 2001)]
[Notices]
[Pages 374-375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-48]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1489]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Sterility Requirements for Aqueous-Based Drug 
Products for Oral Inhalation (Formerly Known and Approved Under 
Sterility Requirements for Inhalation Solution Products) (OMB Control 
Number 0910-0353)

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 
February 2, 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: 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:  In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Sterility Requirements for Aqueous-Based Drug Products for Oral 
Inhalation (Formerly Known and Approved Under Sterility 
Requirements for Inhalation Solution Products) (OMB Control Number 
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

[[Page 375]]

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:

                                                      Table 1.-Estimated Annual Reporting Burden\1\
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                                                                  Annual Frequency      Total Annual
               21 CFR Section                No. of Respondents     per Response          Responses      Hours per Response          Total Hours
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314.97                                                       7                   1                   7                 160         1,120\2\
314.70                                                       2                   1                   2                  20            40\3\
Total                                                                                                                                 1,160
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\1\ There are no capital costs or operating and maintenance 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
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                                                            No. of         Annual Frequency      Total Annual
                   21 CFR Section                        Recordkeepers     per Recordkeepers        Records        Hours per Record       Total Hours
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211.113(b)                                                            9                   1                   9                   2                  18
Total                                                                                                                                                18
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    In the Federal Register of September 18, 2000 (65 FR 56314), the 
agency requested comments on the proposed collections of information. 
No comments were received.

    Dated: December 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-48 Filed 1-2-01; 8:45 am]
BILLING CODE: 4160-01-S