57972 Federal Register / Vol. 71, No.

190 / Monday, October 2, 2006 / Notices

program, or to a grantee of a CMS- SAFEGUARDS: name, if applicable), HICN, and/or SSN

administered grant program, when CMS has safeguards in place for (furnishing the SSN is voluntary, but it
disclosure is deemed reasonably authorized users and monitors such may make searching for a record easier
necessary by CMS to prevent, deter, users to ensure against excessive or and prevent delay).
discover, detect, investigate, examine, unauthorized use. Personnel having
RECORD ACCESS PROCEDURE:
prosecute, sue with respect to, defend access to the system have been trained
against, correct, remedy, or otherwise in the Privacy Act and information For purpose of access, use the same
combat fraud, waste, and abuse in such security requirements. Employees who procedures outlined in Notification
program. maintain records in this system are Procedures above. Requestors should
6. To assist another Federal agency or instructed not to release data until the also reasonably specify the record
to an instrumentality of any intended recipient agrees to implement contents being sought. (These
governmental jurisdiction within or appropriate management, operational procedures are in accordance with
under the control of the United States and technical safeguards sufficient to Department regulation 45 CFR
(including any State or local protect the confidentiality, integrity and 5b.5(a)(2).)
governmental agency), that administers, availability of the information and CONTESTING RECORD PROCEDURES:
or that has the authority to investigate information systems and to prevent
The subject individual should contact
potential fraud, waste, and abuse in, a unauthorized access.
This system will conform to all the system manager named above, and
health benefits program funded in reasonably identify the record and
whole or in part by Federal funds, when applicable Federal laws and regulations
and Federal, HHS, and CMS policies specify the information to be contested.
disclosure is deemed reasonably State the corrective action sought and
necessary by CMS to prevent, deter, and standards as they relate to
information security and data privacy. the reasons for the correction with
discover, detect, investigate, examine, supporting justification. (These
prosecute, sue with respect to, defend These laws and regulations may apply
but are not limited to: The Privacy Act procedures are in accordance with
against, correct, remedy, or otherwise Department regulation 45 CFR 5b.7).
combat fraud, waste, and abuse in such of 1974; the Federal Information
programs. Security Management Act of 2002; the RECORDS SOURCE CATEGORIES:
B. Additional Provisions Affecting Computer Fraud and Abuse Act of 1986; Information maintained in this system
Routine Use Disclosures. the Health Insurance Portability and will be collected from physicians
Accountability Act of 1996; the E- volunteering to participate in the RHD.
To the extent this system contains
Government Act of 2002, the Clinger- Additional data will be collected from
Protected Health Information (PHI) as
Cohen Act of 1996; the Medicare Medicare claims payment records.
defined by HHS regulation ‘‘Standards
Modernization Act of 2003, and the
for Privacy of Individually Identifiable
corresponding implementing SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
Health Information’’ (45 CFR parts 160 OF THE ACT:
regulations. OMB Circular A–130,
and 164, subparts A and E) 65 FR 82462
Management of Federal Resources, None.
(12–28–00). Disclosures of such PHI that
Appendix III, Security of Federal
are otherwise authorized by these [FR Doc. E6–16107 Filed 9–29–06; 8:45 am]
Automated Information Resources also
routine uses may only be made if, and BILLING CODE 4120–03–P
applies. Federal, HHS, and CMS
as, permitted or required by the
policies and standards include but are
‘‘Standards for Privacy of Individually
not limited to: All pertinent National DEPARTMENT OF HEALTH AND
Identifiable Health Information.’’ (See
Institute of Standards and Technology HUMAN SERVICES
45 CFR 164.512(a)(1)).
publications; the HHS Information
In addition, our policy will be to Systems Program Handbook and the
prohibit release even of data not directly Food and Drug Administration
CMS Information Security Handbook.
identifiable, except pursuant to one of [Docket No. 2006N–0211]
the routine uses or if required by law, RETENTION AND DISPOSAL:
if we determine there is a possibility CMS will retain information for a total Agency Information Collection
that an individual can be identified period not to exceed 25 years. All Activities; Submission for Office of
through implicit deduction based on claims-related records are encompassed Management and Budget Review;
small cell sizes (instances where the by the document preservation order and Comment Request; Proposed
patient population is so small that will be retained until notification is Collection; Comment Request;
because of the small size, use of this received from DOJ. Guidance for Industry on Submitting
information could allow for the and Reviewing Complete Responses to
SYSTEM MANAGER AND ADDRESS: Clinical Holds
deduction of the identity of the
beneficiary). Director, Division of Deliver Systems
Demonstration, Office of Research AGENCY: Food and Drug Administration,
POLICIES AND PRACTICES FOR STORING, Development and Information, Mail HHS.
RETRIEVING, ACCESSING, RETAINING, AND Stop C4–18–03, Centers for Medicare & ACTION: Notice.
DISPOSING OF RECORDS IN THE SYSTEM: Medicaid Services, 7500 Security
SUMMARY: The Food and Drug
STORAGE: Boulevard, Baltimore, MD 21244–1849.
Administration (FDA) is announcing
All records are stored on electronic NOTIFICATION PROCEDURE: that a proposed collection of
media. For purpose of access, the subject information has been submitted to the
Office of Management and Budget
rmajette on PROD1PC67 with NOTICES1

individual should write to the system

RETRIEVABILITY: (OMB) for review and clearance under
manager who will require the system
The collected data are retrieved by an name, provider’s tax identification the Paperwork Reduction Act of 1995.
individual identifier; e.g., beneficiary number, national provider number, and DATES: Fax written comments on the
name or HICN, and unique provider for verification purposes, or the subject collection of information by November
identification number. individual’s name (woman’s maiden 1, 2006.

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 Federal Register / Vol. 71, No. 190 / Monday, October 2, 2006 / Notices 57973

ADDRESSES: To ensure that comments on ongoing investigation for a drug or Response’’ in large, bold letters at the
the information collection are received, biologic. An applicant may respond to top of the cover letter of the complete
OMB recommends that written a clinical hold. response to expedite review of the
comments be faxed to the Office of Under section 505(i)(3)(C) of the response. The guidance also requests
Information and Regulatory Affairs, Federal Food, Drug, and Cosmetic Act that applicants submit the complete
OMB, Attn: FDA Desk Officer, FAX: (21 U.S.C. 355(i)(3)(C)), any written response letter in triplicate to the IND,
202–395–6974. request to FDA from the sponsor of an and that they fax a copy of the cover
FOR FURTHER INFORMATION CONTACT: investigation that a clinical hold be letter to the FDA contact listed in the
Elizabeth Berbakos, Office of removed must receive a decision, in clinical hold letter who is responsible
Management Programs (HFA–250), Food writing and specifying the reasons, for the IND. The guidance requests more
and Drug Administration, 5600 Fishers within 30 days after receipt of the than an original and 2 copies of the
Lane, Rockville, MD 20857, 301–827– request. The request must include cover letter in order to ensure that the
1482. sufficient information to support the
submission is received and handled in
SUPPLEMENTARY INFORMATION: In removal of the clinical hold.
a timely manner.
compliance with 44 U.S.C. 3507, FDA In the Federal Register of May 14,
1998 (63 FR 26809), FDA published a Based on data concerning the number
has submitted the following proposed
collection of information to OMB for notice of availability of a guidance that of complete responses to clinical holds
review and clearance. described how applicants should submit received by the Center for Drug
responses to clinical holds so that they Evaluation and Research (CDER) in 2004
Guidance for Industry on Submitting may be identified as complete responses and 2005, CDER estimates that
and Reviewing Complete Responses to and the agency can track the time to approximately 88 responses are
Clinical Holds—(OMB Control Number respond. submitted annually from approximately
0910–0445—(Extension) FDA issued a revised guidance in 67 applicants, and that it takes
Section 117 of the Food and Drug October 2000 which states that FDA will approximately 284 hours to prepare and
Administration Modernization Act respond in writing within 30-calendar submit to CDER each response.
(Public Law 105–115), signed into law days of receipt of a sponsor’s request to
Based on data concerning the number
by the President on November 21, 1997, release a clinical hold and a complete
of complete responses to clinical holds
provides that a written request to FDA response to the issue(s) that led to the
from the applicant of an investigation clinical hold. An applicant’s complete received by the Center for Biologics
that a clinical hold be removed shall response to an investigational new drug Evaluation and Research (CBER) in 2004
receive a decision in writing, specifying (IND) clinical hold is a response in and 2005, CBER estimates that
the reasons for that decision, within 30 which all clinical hold issues identified approximately 92 responses are
days after receipt of such request. A in the clinical hold letter have been submitted annually from approximately
clinical hold is an order issued by FDA addressed. 60 applicants, and that it takes
to the applicant to delay a proposed The guidance requests that applicants approximately 284 hours to prepare and
clinical investigation or to suspend an type ‘‘Clinical Hold Complete submit to CBER each response.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Complete
Responses No. of Responses Per
No. of Respondents Total Annual Responses Hours Per Response Total Hours
to Clinical Respondent
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.

DEPARTMENT OF HEALTH AND proposed collection of certain

In the Federal Register of May 25, HUMAN SERVICES information by the agency. Under the
2006 (71 FR 30142), FDA published a Paperwork Reduction Act of 1995 (the
Food and Drug Administration PRA), Federal agencies are required to
60-day notice requesting public
comment on the information collection [Docket No. 2006N–0382] publish notice in the Federal Register
provisions. No comments were received. concerning each proposed collection of
Agency Information Collection information, including each proposed
Dated: September 26, 2006. Activities; Proposed Collection; extension of an existing information
Jeffrey Shuren, Comment Request; Postmarket collection, and to allow 60 days for
Assistant Commissioner for Policy. Surveillance public comment in response to the
[FR Doc. E6–16225 Filed 9–29–06; 8:45 am] notice. This notice solicits comments on
AGENCY: Food and Drug Administration, information collection requirements for
rmajette on PROD1PC67 with NOTICES1

BILLING CODE 4160–01–S HHS. Postmarket Surveillance under 21 CFR

ACTION: Notice. part 822.
SUMMARY: The Food and Drug DATES:Submit written or electronic
Administration (FDA) is announcing an comments on the collection of
opportunity for public comment on the information by December 1, 2006.

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