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30142 Federal Register / Vol. 71, No.

101 / Thursday, May 25, 2006 / Notices

ANNUAL BURDEN ESTIMATES


Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

HS Grant and Budget Instrument .................................................................... 1,600 1 33 52,800

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND agencies must obtain approval from the
Hours: 52,800. HUMAN SERVICES Office of Management and Budget
In compliance with the requirements (OMB) for each collection of
Food and Drug Administration information they conduct or sponsor.
of Section 3506(c)(2)(A) of the
[Docket No. 2006N–0211] ‘‘Collection of information’’ is defined
Paperwork Reduction Act of 1995, the
in 44 U.S.C. 3502(3) and 5 CFR
Administration for Children and
Agency Information Collection 1320.3(c) and includes agency requests
Families is soliciting public comment or requirements that members of the
Activities; Proposed Collection;
on the specific aspects of the public submit reports, keep records, or
Comment Request; Guidance for
information collection described above. provide information to a third party.
Industry on Submitting and Reviewing
Copies of the proposed collection of Complete Responses to Clinical Holds Section 3506(c)(2)(A) of the PRA (44
information can be obtained and U.S.C. 3506(c)(2)(A)) requires Federal
comments may be forwarded by writing AGENCY: Food and Drug Administration, agencies to provide a 60-day notice in
to the Administration for Children and HHS. the Federal Register concerning each
Families, Office of Administration, ACTION: Notice. proposed collection of information,
Office of Information Services, 370 including each proposed extension of an
SUMMARY: The Food and Drug
L’Enfant Promenade, SW., Washington, Administration (FDA) is announcing an existing collection of information,
DC 20447, Attn: ACF Reports Clearance opportunity for public comment on the before submitting the collection to OMB
Officer. E-mail address: proposed collection of certain for approval. To comply with this
infocollection@acf.hhs.gov. All requests information by the agency. Under the requirement, FDA is publishing notice
should be identified by the title of the Paperwork Reduction Act of 1995 (the of the proposed collection of
information collection. PRA), Federal agencies are required to information set forth in this document.
With respect to the following
The Department specifically requests publish notice in the Federal Register
collection of information, FDA invites
comments on: (a) Whether the proposed concerning each proposed collection of
information, including each proposed comments on these topics: (1) Whether
collection of information is necessary the proposed collection of information
for the proper performance of the extension of an existing collection of
information, and to allow 60 days for is necessary for the proper performance
functions of the agency, including of FDA’s functions, including whether
whether the information shall have public comment in response to the
notice. This notice solicits comments on the information will have practical
practical utility; (b) the accuracy of the utility; (2) the accuracy of FDA’s
the collection of information contained
agency’s estimate of the burden of the estimate of the burden of the proposed
in a guidance for industry entitled
proposed collection of information; (c) ‘‘Submitting and Reviewing Complete collection of information, including the
the quality, utility, and clarity of the Responses to Clinical Holds.’’ The validity of the methodology and
information to be collected; and (d) guidance describes how to submit a assumptions used; (3) ways to enhance
ways to minimize the burden of the complete response if an investigational the quality, utility, and clarity of the
collection of information on new drug (IND) application is placed on information to be collected; and (4)
respondents, including through the use clinical hold by FDA. ways to minimize the burden of the
of automated collection techniques or DATES: Submit written or electronic
collection of information on
other forms of information technology. comments on the collection of respondents, including through the use
Consideration will be given to information by July 24, 2006. of automated collection techniques,
comments and suggestions submitted when appropriate, and other forms of
ADDRESSES: Submit electronic
within 60 days of this publication. information technology.
comments on the collection to: http://
Dated: May 18, 2006. www.fda.gov/dockets/ecomments. Guidance for Industry: Submitting and
Robert Sargis, Submit written comments on the Reviewing Complete Responses to
collection of information to the Division Clinical Holds (OMB Control Number
Reports Clearance Officer. 0910–0445)—Extension
of Dockets Management (HFA–305),
[FR Doc. 06–4851 Filed 5–24–06; 8:45 am] Food and Drug Administration, 5630 Section 117 of the Food and Drug
BILLING CODE 4184–01–M Fishers Lane, rm. 1061 Rockville, MD Administration Modernization Act
20852. All comments should be (Public Law 105–115), signed into law
identified with the docket number by the President on November 21, 1997,
found in brackets in the heading of this provides that a written request to FDA
document. from the applicant of an investigation
FOR FURTHER INFORMATION CONTACT: that a clinical hold be removed shall
Karen Nelson, Office of Management receive a decision in writing, specifying
cchase on PROD1PC60 with NOTICES

Programs (HFA–250), Food and Drug the reasons for that decision, within 30
Administration, 5600 Fishers Lane, days after receipt of such request. A
Rockville, MD 20857, 301– 827–1482. clinical hold is an order issued by FDA
SUPPLEMENTARY INFORMATION: Under the to the applicant to delay a proposed
PRA (44 U.S.C. 3501–3520), Federal clinical investigation or to suspend an

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Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Notices 30143

ongoing investigation for a drug or respond in writing within 30 calendar submission is received and handled in
biologic. An applicant may respond to days of receipt of a sponsor’s request to a timely manner.
a clinical hold. release a clinical hold and a complete Based on data concerning the number
Under section 505(i)(3)(C) of the response to the issue(s) that led to the of complete responses to clinical holds
Federal Food, Drug, and Cosmetic Act clinical hold. An applicant’s complete
(21 U.S.C. 355), any written request to received by the Center for Drug
response to an IND clinical hold is a Evaluation and Research (CDER) in 2004
FDA from the sponsor of an response in which all clinical hold
investigation that a clinical hold be and 2005, CDER estimates that
issues identified in the clinical hold
removed must receive a decision, in approximately 88 responses are
letter have been addressed.
writing and specifying the reasons, submitted annually from approximately
within 30 days after receipt of the The guidance requests that applicants 67 applicants, and that it takes
request. The request must include type ‘‘Clinical Hold Complete approximately 284 hours to prepare and
sufficient information to support the Response’’ in large, bold letters at the submit to CDER each response.
removal of the clinical hold. top of the cover letter of the complete
response to expedite review of the Based on data concerning the number
In the Federal Register of May 14, of complete responses to clinical holds
1998 (63 FR 26809), FDA published a response. The guidance also requests
that applicants submit the complete received by the Center for Biologics
notice of availability of a guidance that
response letter in triplicate to the IND, Evaluation and Research (CBER) in 2004
described how applicants should submit
and that they fax a copy of the cover and 2005, CBER estimates that
responses to clinical holds so that they
may be identified as complete responses letter to FDA’s contact listed in the approximately 92 responses are
and the agency can track the time to clinical hold letter who is responsible submitted annually from approximately
respond. for the IND. The guidance requests more 60 applicants, and that it takes
FDA issued a revised guidance in than an original and two copies of the approximately 284 hours to prepare and
October 2000 which states that FDA will cover letter in order to ensure that the submit to CBER each response.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1


Complete Re- No. of Responses Per
sponses to No. of Respondents Total Annual Responses Hours Per Response Total Hours
Respondent
Clinical Holds

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. the Paperwork Reduction Act of 1995 Aluminum in Large and Small Volume
Jeffrey Shuren, (the PRA). Parenterals Used in Total Parenteral
Assistant Commissioner for Policy. Nutrition—21 CFR 201.323—(OMB
DATES: Fax written comments on the
[FR Doc. E6–7983 Filed 5–24–06; 8:45 am] Control Number 0910–0439)—Extension
collection of information by June 26,
BILLING CODE 4160–01–S
2006. FDA is requesting OMB approval
under the PRA (44 U.S.C. 3501–3520),
ADDRESSES: OMB is still experiencing for the labeling requirements for
DEPARTMENT OF HEALTH AND significant delays in the regular mail,
HUMAN SERVICES aluminum content in large volume
including first class and express mail, parenterals (LVPs), small volume
Food and Drug Administration and messenger deliveries are not being parenterals (SVPs), and pharmacy bulk
accepted. To ensure that comments on packages (PBPs) used in total parenteral
the information collection are received, nutrition (TPN). As explained in the
[Docket No. 2006N–0080]
OMB recommends that written final rule on aluminum content labeling
Agency Information Collection comments be faxed to the Office of requirements published in the Federal
Activities; Submission for Office of Information and Regulatory Affairs, Register of January 26, 2000 (65 FR
Management and Budget Review; OMB, Attn: Fumie Yokota, Desk Officer 4103) (the January 2000 final rule),
Comment Request; Aluminum in Large for FDA, FAX: 202–395–6974. aluminum content in parenteral drug
and Small Volume Parenterals Used in FOR FURTHER INFORMATION CONTACT:
products could result in a toxic
Total Parenteral Nutrition Karen L. Nelson, Office of Management accumulation of aluminum in the
tissues of individuals receiving TPN
AGENCY: Food and Drug Administration, Programs (HFA–250), Food and Drug
therapy. Research indicates that
HHS. Administration, 5600 Fishers Lane,
neonates and patient populations with
Rockville, MD 20857, 301–827–1482.
ACTION: Notice. impaired kidney function may be at
SUPPLEMENTARY INFORMATION: In high risk of exposure to unsafe amounts
SUMMARY: The Food and Drug compliance with 44 U.S.C. 3507, FDA of aluminum. Studies show that
cchase on PROD1PC60 with NOTICES

Administration (FDA) is announcing has submitted the following proposed aluminum may accumulate in the bone,
that a proposed collection of collection of information to OMB for urine, and plasma of infants receiving
information has been submitted to the review and clearance. TPN. Many drug products used
Office of Management and Budget routinely in parenteral therapy may
(OMB) for review and clearance under contain levels of aluminum sufficiently

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