Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds, 30142-30143 [E6-7983]
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30142
Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
HS Grant and Budget Instrument ....................................................................
1,600
1
33
52,800
Estimated Total Annual Burden
Hours: 52,800.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: May 18, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–4851 Filed 5–24–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0211]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Submitting and Reviewing
Complete Responses to Clinical Holds
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information contained
in a guidance for industry entitled
‘‘Submitting and Reviewing Complete
Responses to Clinical Holds.’’ The
guidance describes how to submit a
complete response if an investigational
new drug (IND) application is placed on
clinical hold by FDA.
DATES: Submit written or electronic
comments on the collection of
information by July 24, 2006.
ADDRESSES: Submit electronic
comments on the collection to: https://
www.fda.gov/dockets/ecomments.
Submit written comments on the
collection of information to the Division
of Dockets Management (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 Nelson, Office of Management
Programs (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
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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 these topics: (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.
Guidance for Industry: Submitting and
Reviewing Complete Responses to
Clinical Holds (OMB Control Number
0910–0445)—Extension
Section 117 of the Food and Drug
Administration Modernization Act
(Public Law 105–115), signed into law
by the President on November 21, 1997,
provides that a written request to FDA
from the applicant of an investigation
that a clinical hold be removed shall
receive a decision in writing, specifying
the reasons for that decision, within 30
days after receipt of such request. A
clinical hold is an order issued by FDA
to the applicant to delay a proposed
clinical investigation or to suspend an
E:\FR\FM\25MYN1.SGM
25MYN1
Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Notices
ongoing investigation for a drug or
biologic. An applicant may respond to
a clinical hold.
Under section 505(i)(3)(C) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355), any written request to
FDA from the sponsor of an
investigation that a clinical hold be
removed must receive a decision, in
writing and specifying the reasons,
within 30 days after receipt of the
request. The request must include
sufficient information to support the
removal of the clinical hold.
In the Federal Register of May 14,
1998 (63 FR 26809), FDA published a
notice of availability of a guidance that
described how applicants should submit
responses to clinical holds so that they
may be identified as complete responses
and the agency can track the time to
respond.
FDA issued a revised guidance in
October 2000 which states that FDA will
respond in writing within 30 calendar
days of receipt of a sponsor’s request to
release a clinical hold and a complete
response to the issue(s) that led to the
clinical hold. An applicant’s complete
response to an IND clinical hold is a
response in which all clinical hold
issues identified in the clinical hold
letter have been addressed.
The guidance requests that applicants
type ‘‘Clinical Hold Complete
Response’’ in large, bold letters at the
top of the cover letter of the complete
response to expedite review of the
response. The guidance also requests
that applicants submit the complete
response letter in triplicate to the IND,
and that they fax a copy of the cover
letter to FDA’s contact listed in the
clinical hold letter who is responsible
for the IND. The guidance requests more
than an original and two copies of the
cover letter in order to ensure that the
30143
submission is received and handled in
a timely manner.
Based on data concerning the number
of complete responses to clinical holds
received by the Center for Drug
Evaluation and Research (CDER) in 2004
and 2005, CDER estimates that
approximately 88 responses are
submitted annually from approximately
67 applicants, and that it takes
approximately 284 hours to prepare and
submit to CDER each response.
Based on data concerning the number
of complete responses to clinical holds
received by the Center for Biologics
Evaluation and Research (CBER) in 2004
and 2005, CBER estimates that
approximately 92 responses are
submitted annually from approximately
60 applicants, and that it takes
approximately 284 hours to prepare and
submit to CBER each response.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Complete Responses to
Clinical Holds
No. of Responses Per
Respondent
No. of Respondents
Total Annual Responses
Hours Per Response
Total Hours
CDER
67
.76
88
284
24,992
CBER
60
1.53
92
284
26,128
Total
51,120
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7983 Filed 5–24–06; 8:45 am]
the Paperwork Reduction Act of 1995
(the PRA).
Fax written comments on the
collection of information by June 26,
2006.
DATES:
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. 2006N–0080]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Aluminum in Large
and Small Volume Parenterals Used in
Total Parenteral Nutrition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
cchase on PROD1PC60 with NOTICES
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
SUMMARY:
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Aluminum in Large and Small Volume
Parenterals Used in Total Parenteral
Nutrition—21 CFR 201.323—(OMB
Control Number 0910–0439)—Extension
FDA is requesting OMB approval
under the PRA (44 U.S.C. 3501–3520),
for the labeling requirements for
aluminum content in large volume
parenterals (LVPs), small volume
parenterals (SVPs), and pharmacy bulk
packages (PBPs) used in total parenteral
nutrition (TPN). As explained in the
final rule on aluminum content labeling
requirements published in the Federal
Register of January 26, 2000 (65 FR
4103) (the January 2000 final rule),
aluminum content in parenteral drug
products could result in a toxic
accumulation of aluminum in the
tissues of individuals receiving TPN
therapy. Research indicates that
neonates and patient populations with
impaired kidney function may be at
high risk of exposure to unsafe amounts
of aluminum. Studies show that
aluminum may accumulate in the bone,
urine, and plasma of infants receiving
TPN. Many drug products used
routinely in parenteral therapy may
contain levels of aluminum sufficiently
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]]>Agencies
[Federal Register Volume 71, Number 101 (Thursday, May 25, 2006)]
[Notices]
[Pages 30142-30143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0211]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Submitting and Reviewing
Complete Responses to Clinical Holds
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
contained in a guidance for industry entitled ``Submitting and
Reviewing Complete Responses to Clinical Holds.'' The guidance
describes how to submit a complete response if an investigational new
drug (IND) application is placed on clinical hold by FDA.
DATES: Submit written or electronic comments on the collection of
information by July 24, 2006.
ADDRESSES: Submit electronic comments on the collection to: https://
www.fda.gov/dockets/ecomments. Submit written comments on the
collection of information to the Division of Dockets Management (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 Nelson, Office of Management
Programs (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 these topics: (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.
Guidance for Industry: Submitting and Reviewing Complete Responses to
Clinical Holds (OMB Control Number 0910-0445)--Extension
Section 117 of the Food and Drug Administration Modernization Act
(Public Law 105-115), signed into law by the President on November 21,
1997, provides that a written request to FDA from the applicant of an
investigation that a clinical hold be removed shall receive a decision
in writing, specifying the reasons for that decision, within 30 days
after receipt of such request. A clinical hold is an order issued by
FDA to the applicant to delay a proposed clinical investigation or to
suspend an
[[Page 30143]]
ongoing investigation for a drug or biologic. An applicant may respond
to a clinical hold.
Under section 505(i)(3)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355), any written request to FDA from the sponsor of an
investigation that a clinical hold be removed must receive a decision,
in writing and specifying the reasons, within 30 days after receipt of
the request. The request must include sufficient information to support
the removal of the clinical hold.
In the Federal Register of May 14, 1998 (63 FR 26809), FDA
published a notice of availability of a guidance that described how
applicants should submit responses to clinical holds so that they may
be identified as complete responses and the agency can track the time
to respond.
FDA issued a revised guidance in October 2000 which states that FDA
will respond in writing within 30 calendar days of receipt of a
sponsor's request to release a clinical hold and a complete response to
the issue(s) that led to the clinical hold. An applicant's complete
response to an IND clinical hold is a response in which all clinical
hold issues identified in the clinical hold letter have been addressed.
The guidance requests that applicants type ``Clinical Hold Complete
Response'' in large, bold letters at the top of the cover letter of the
complete response to expedite review of the response. The guidance also
requests that applicants submit the complete response letter in
triplicate to the IND, and that they fax a copy of the cover letter to
FDA's contact listed in the clinical hold letter who is responsible for
the IND. The guidance requests more than an original and two copies of
the cover letter in order to ensure that the submission is received and
handled in a timely manner.
Based on data concerning the number of complete responses to
clinical holds received by the Center for Drug Evaluation and Research
(CDER) in 2004 and 2005, CDER estimates that approximately 88 responses
are submitted annually from approximately 67 applicants, and that it
takes approximately 284 hours to prepare and submit to CDER each
response.
Based on data concerning the number of complete responses to
clinical holds received by the Center for Biologics Evaluation and
Research (CBER) in 2004 and 2005, CBER estimates that approximately 92
responses are submitted annually from approximately 60 applicants, and
that it takes approximately 284 hours to prepare and submit to CBER
each response.
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complete Responses to Clinical No. of Responses Per
Holds No. of Respondents Respondent Total Annual Responses Hours Per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER 67 .76 88 284 24,992
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER 60 1.53 92 284 26,128
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 51,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7983 Filed 5-24-06; 8:45 am]
BILLING CODE 4160-01-S
