Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Proposed Collection; Comment Request; Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds, 57972-57973 [E6-16225]
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57972
Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices
program, or to a grantee of a CMSadministered grant program, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste, and abuse in such
program.
6. To assist another Federal agency or
to an instrumentality of any
governmental jurisdiction within or
under the control of the United States
(including any State or local
governmental agency), that administers,
or that has the authority to investigate
potential fraud, waste, and abuse in, a
health benefits program funded in
whole or in part by Federal funds, when
disclosure is deemed reasonably
necessary by CMS to prevent, deter,
discover, detect, investigate, examine,
prosecute, sue with respect to, defend
against, correct, remedy, or otherwise
combat fraud, waste, and abuse in such
programs.
B. Additional Provisions Affecting
Routine Use Disclosures.
To the extent this system contains
Protected Health Information (PHI) as
defined by HHS regulation ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (45 CFR parts 160
and 164, subparts A and E) 65 FR 82462
(12–28–00). Disclosures of such PHI that
are otherwise authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’ (See
45 CFR 164.512(a)(1)).
In addition, our policy will be to
prohibit release even of data not directly
identifiable, except pursuant to one of
the routine uses or if required by law,
if we determine there is a possibility
that an individual can be identified
through implicit deduction based on
small cell sizes (instances where the
patient population is so small that
because of the small size, use of this
information could allow for the
deduction of the identity of the
beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
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All records are stored on electronic
media.
The collected data are retrieved by an
individual identifier; e.g., beneficiary
name or HICN, and unique provider
identification number.
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CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: The Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: All pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
name, if applicable), HICN, and/or SSN
(furnishing the SSN is voluntary, but it
may make searching for a record easier
and prevent delay).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR
5b.5(a)(2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7).
RECORDS SOURCE CATEGORIES:
Information maintained in this system
will be collected from physicians
volunteering to participate in the RHD.
Additional data will be collected from
Medicare claims payment records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E6–16107 Filed 9–29–06; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0211]
RETENTION AND DISPOSAL:
CMS will retain information for a total
period not to exceed 25 years. All
claims-related records are encompassed
by the document preservation order and
will be retained until notification is
received from DOJ.
SYSTEM MANAGER AND ADDRESS:
Director, Division of Deliver Systems
Demonstration, Office of Research
Development and Information, Mail
Stop C4–18–03, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244–1849.
NOTIFICATION PROCEDURE:
RETRIEVABILITY:
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SAFEGUARDS:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, provider’s tax identification
number, national provider number, and
for verification purposes, or the subject
individual’s name (woman’s maiden
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
1, 2006.
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02OCN1
Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices
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: FDA Desk Officer, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Management Programs (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.
ADDRESSES:
Guidance for Industry on 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
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(i)(3)(C)), 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 investigational new drug
(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
57973
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 the FDA contact listed in the
clinical hold letter who is responsible
for the IND. The guidance requests more
than an original and 2 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 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
1There
51,120
are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of May 25,
2006 (71 FR 30142), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
rmajette on PROD1PC67 with NOTICES1
Dated: September 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–16225 Filed 9–29–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0382]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarket
Surveillance
AGENCY:
Food and Drug Administration,
HHS.
BILLING CODE 4160–01–S
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
VerDate Aug<31>2005
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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 information
collection, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
Postmarket Surveillance under 21 CFR
part 822.
Submit written or electronic
comments on the collection of
information by December 1, 2006.
DATES:
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]]>Agencies
[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57972-57973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16225]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0211]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 1, 2006.
[[Page 57973]]
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Management Programs (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.
Guidance for Industry on 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 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(i)(3)(C)), 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 investigational new drug (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
the FDA contact listed in the clinical hold letter who is responsible
for the IND. The guidance requests more than an original and 2 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.
In the Federal Register of May 25, 2006 (71 FR 30142), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: September 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16225 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S
