[Federal Register: January 3, 2001 (Volume 66, Number 2)]
[Notices]
[Page 374-375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja01-60]
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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