Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability, 61692-61693 [E9-28247]
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Federal Register / Vol. 74, No. 226 / Wednesday, November 25, 2009 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of hospitals
Form name
Total burden
hours
Average hourly
wate rate*
Total cost burden
Culture Questionnaire ......................................................................
Implementation Assessment Questionnaire ....................................
Patient Healthcare Use Questionnaire ............................................
7
7
200
525
84
50
$38.28
$45.33
$21.90
$20,097
$3,808
$1,095
Total ..........................................................................................
226
2,430
na
$76,118
*Based upon the mean of the average wages for Nursing Care Providers ($30.03), Primary Care Physicians ($84.97), Allied Health Providers
($20.98), Administrators, Chief Executives ($76.23) and All Workers ($21.90); National Compensation Survey: Occupational wages in the United
States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Estimated Annual Costs to the Federal
Government
Federal Government over a two-year
period. The total cost of this project is
$1.8 million dollars which includes
$785,000 for project development,
$70,000 for data collection activities,
Exhibit 3 shows the total and
annualized cost of this project to the
$235,000 for data analysis, $125,000 for
publication of the results, $170,000 for
project management and $415,000 for
overhead costs.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Annualized cost
Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Publication of Results ......................................................................................................................................
Project Management ........................................................................................................................................
Overhead .........................................................................................................................................................
$785,000
$70,000
$235,000
$125,000
$170,000
$415,000
$262,000
$35,000
$78,000
$125,000
$57,000
$138,000
Total ..........................................................................................................................................................
$1,800,000
$900,000
sroberts on DSKD5P82C1PROD with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Nov<24>2008
17:36 Nov 24, 2009
Jkt 220001
Dated: November 16, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–28211 Filed 11–24–09; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0413]
Guidance for Industry on Residual
Solvents in Drug Products Marketed in
the United States; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Residual Solvents in Drug
Products Marketed in the United
States.’’ On July 1, 2008, the United
States Pharmacopeia (USP) published a
new test requirement for the control of
residual solvents, General Chapter
<467> ‘‘Residual Solvents,’’ which
replaced USP General Chapter <467>
‘‘Organic Volatile Impurities.’’ The
change affects all compendial drug
products marketed in the United States.
This guidance reflects FDA’s
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
recommendations on how to comply
with those USP changes.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov . See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Chris Watts, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 4142 Silver Spring,
MD 20993–0002, 301–796–1625.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 74, No. 226 / Wednesday, November 25, 2009 / Notices
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Residual Solvents in Drug Products
Marketed in the United States.’’ On
August 7, 2008 (73 FR 46020), FDA
announced the availability of the draft
version of this guidance. The public
comment period closed on October 6,
2008. A number of comments were
received, which the agency considered
carefully as it finalized the guidance. In
response to the comments, FDA made
appropriate changes. The guidance
provides information on how new drug
application (NDA) and abbreviated new
drug application (ANDA) applicants for
noncompendial drug products should
limit residual solvents as described in
the International Conference on
Harmonisation guidance for industry
‘‘Q3C Impurities: Residual Solvents;’’
how manufacturers of compendial drug
products that are not marketed under an
approved NDA or ANDA can comply
with the new General Chapter <467>
and the Federal Food, Drug, and
Cosmetic Act; and how holders of NDAs
or ANDAs for compendial drug
products should report changes in
chemistry, manufacturing, and controls
specifications to FDA to comply with
the USP General Chapter <467>
‘‘Residual Solvents’’ and § 314.70 (21
CFR 314.70).
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on USP General
Chapter <467> ‘‘Residual Solvents.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
sroberts on DSKD5P82C1PROD with NOTICES
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). Information submitted in the
chemistry, manufacturing, and controls
section of an application under 21 CFR
314.50(d)(1), as well as in amendments
to pending applications under 21 CFR
314.60, is approved by OMB under
Control Number 0910–0001.
Information submitted in an annual
report under § 314.70(d)(2)(i) and (d)(3)
is approved by OMB under Control
VerDate Nov<24>2008
17:36 Nov 24, 2009
Jkt 220001
61693
Number 0910–0001. Recordkeeping
required under 21 CFR 211.165(e) and
211.194(a)(2) is approved by OMB
under Control Number 0910–0139.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Comments
Center for Scientific Review; Notice of
Meeting
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper 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 Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28247 Filed 11–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board, November 30, 2009,
6:30 p.m. to December 2, 2009, 12 p.m.,
National Institutes of Health, Building
31, 31 Center Drive, 10, Bethesda, MD,
20892 which was published in the
Federal Register on November 4, 2009,
74FR57182.
This Federal Register Notice is being
amended to reflect the change in the
start and end times of the closed session
on December 1, 2009 to 3:45 p.m. to
4:30 p.m.
Dated: November 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–28279 Filed 11–24–09; 8:45 am]
National Institutes of Health
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Institutes of Health Peer
Review Advisory Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Institutes of
Health Peer Review Advisory Committee.
Date: February 1, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: Provide technical and scientific
advice and recommendations to the NIH
Director, the Deputy Director for Extramural
Research, and the Director of the Center for
Scientific Review (CSR) on all procedures
and policies related to the process of peer
review by which the scientific and technical
merit of NIH grant applications is assessed.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Cheryl A. Kitt, PhD, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3030,
MSC 7776, Bethesda, MD 20892, 301–435–
1112, kittc@csr.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 17, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–28287 Filed 11–24–09; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 74, Number 226 (Wednesday, November 25, 2009)]
[Notices]
[Pages 61692-61693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0413]
Guidance for Industry on Residual Solvents in Drug Products
Marketed in the United States; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Residual Solvents in
Drug Products Marketed in the United States.'' On July 1, 2008, the
United States Pharmacopeia (USP) published a new test requirement for
the control of residual solvents, General Chapter <467> ``Residual
Solvents,'' which replaced USP General Chapter <467> ``Organic Volatile
Impurities.'' The change affects all compendial drug products marketed
in the United States. This guidance reflects FDA's recommendations on
how to comply with those USP changes.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Chris Watts, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4142 Silver Spring, MD 20993-0002, 301-
796-1625.
SUPPLEMENTARY INFORMATION:
[[Page 61693]]
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Residual Solvents in Drug Products Marketed in the United
States.'' On August 7, 2008 (73 FR 46020), FDA announced the
availability of the draft version of this guidance. The public comment
period closed on October 6, 2008. A number of comments were received,
which the agency considered carefully as it finalized the guidance. In
response to the comments, FDA made appropriate changes. The guidance
provides information on how new drug application (NDA) and abbreviated
new drug application (ANDA) applicants for noncompendial drug products
should limit residual solvents as described in the International
Conference on Harmonisation guidance for industry ``Q3C Impurities:
Residual Solvents;'' how manufacturers of compendial drug products that
are not marketed under an approved NDA or ANDA can comply with the new
General Chapter <467> and the Federal Food, Drug, and Cosmetic Act; and
how holders of NDAs or ANDAs for compendial drug products should report
changes in chemistry, manufacturing, and controls specifications to FDA
to comply with the USP General Chapter <467> ``Residual Solvents'' and
Sec. 314.70 (21 CFR 314.70).
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on USP General Chapter <467> ``Residual
Solvents.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Information submitted in the chemistry, manufacturing, and controls
section of an application under 21 CFR 314.50(d)(1), as well as in
amendments to pending applications under 21 CFR 314.60, is approved by
OMB under Control Number 0910-0001. Information submitted in an annual
report under Sec. 314.70(d)(2)(i) and (d)(3) is approved by OMB under
Control Number 0910-0001. Recordkeeping required under 21 CFR
211.165(e) and 211.194(a)(2) is approved by OMB under Control Number
0910-0139.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: November 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28247 Filed 11-24-09; 8:45 am]
BILLING CODE 4160-01-S
