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27140 Federal Register / Vol. 72, No.

92 / Monday, May 14, 2007 / Notices

Table 1 of this document provides a PRA), Federal agencies are required to validity of the methodology and
breakdown of the total estimated annual publish notice in the Federal Register assumptions used; (3) ways to enhance
recordkeeping burden. FDA bases this concerning each proposed collection of the quality, utility, and clarity of the
hour burden estimate on its experience information, including each proposed information to be collected; and (4)
with the application of HACCP extension of an existing collection of ways to minimize the burden of the
principles in food processing. information, and to allow 60 days for collection of information on
The burden estimates in table 1 of this public comment in response to the respondents, including through the use
document are based on an estimate of notice. This notice solicits comments on of automated collection techniques,
the total number of juice manufacturing the collection of information contained when appropriate, and other forms of
plants (i.e., 2,300) affected by the in the guidance entitled ‘‘Information information technology.
regulations. Included in this total are Program on Clinical Trials for Serious or
Information Program on Clinical Trials
850 plants currently identified in FDA’s Life-Threatening Diseases and
for Serious or Life-Threatening
official establishment inventory plus Conditions’’ dated March 18, 2002.
Diseases: Maintaining a Data Bank
1,220 very small apple juice DATES: Submit written or electronic (OMB Control Number 0910–0459)—
manufacturers and 230 very small comments on the collection of Extension
orange juice manufacturers. The total information by July 13, 2007.
burden hours are derived by estimating ADDRESSES: Submit electronic
In the Federal Register of March 18,
the number of plants affected by each comments on the collection of 2002 (65 FR 12022), FDA issued a
portion of this final rule and information to: http://www.fda.gov/ guidance to industry on
multiplying the corresponding number dockets/ecomments. Submit written recommendations for investigational
by the number of records required comments on the collection of new drug application (IND) sponsors on
annually and the hours needed to information to the Division of Dockets submitting information about clinical
complete the record. These numbers Management (HFA–305), Food and Drug trials for serious or life- threatening
were obtained from the agency’s final Administration, 5630 Fishers Lane, rm. diseases to a Clinical Trials Data Bank
regulatory impact analysis prepared for 1061, Rockville, MD 20852. All developed by the National Library of
these regulations. comments should be identified with the Medicine (NLM), National Institutes of
Moreover, these estimates assume that docket number found in brackets in the Health (NIH). This information is
every processor will prepare sanitary heading of this document. especially important for patients and
standard operating procedures and a their families seeking opportunities to
participate in clinical trials of new drug
HACCP plan and maintain the Jonna Capezzuto, Office of the Chief treatments for serious or life-threatening
associated monitoring records and that Information Officer (HFA–250), Food diseases. The guidance describes three
every importer will require product and Drug Administration, 5600 Fishers collections of information: Mandatory
safety specifications. In fact, there are Lane, Rockville, MD 20857, 301–827– submissions, voluntary submissions,
likely to be some small number of juice 4659. and certifications.
processors that, based upon their hazard SUPPLEMENTARY INFORMATION: Under the
analysis, determine that they are not PRA (44 U.S.C. 3501–3520), Federal Mandatory Submissions
required to have a HACCP plan under agencies must obtain approval from the Section 113 of the Food and Drug
these regulations. Office of Management and Budget Administration Modernization Act
Dated: April 27, 2007. (OMB) for each collection of (FDAMA) of 1997 (the Modernization
Jeffrey Shuren, information they conduct or sponsor. Act) (Public Law 105–115) requires that
Assistant Commissioner for Policy. ‘‘Collection of information’’ is defined sponsors shall submit information to the
[FR Doc. E7–9220 Filed 5–11–07; 8:45 am] in 44 U.S.C. 3502(3) and 5 CFR Clinical Trials Data Bank when the
1320.3(c) and includes agency requests clinical trial: (1) Involves a treatment for
or requirements that members of the a serious or life-threatening disease and
public submit reports, keep records, or (2) is intended to assess the
DEPARTMENT OF HEALTH AND provide information to a third party. effectiveness of the treatment. The
HUMAN SERVICES Section 3506(c)(2)(A) of the PRA (44 guidance discusses how sponsors can
U.S.C. 3506(c)(2)(A)) requires Federal fulfill the requirements of section 113 of
Food and Drug Administration agencies to provide a 60-day notice in the Modernization Act. Specifically,
the Federal Register concerning each sponsors should provide: (1)
[Docket No. 2007N–0182]
proposed collection of information, Information about clinical trials, both
Agency Information Collection including each proposed extension of an federally and privately funded, of
Activities; Proposed Collection; existing collection of information, experimental treatments (drugs,
Comment Request; Information before submitting the collection to OMB including biological products) for
Program on Clinical Trials for Serious for approval. To comply with this patients with serious or life-threatening
or Life-Threatening Diseases: requirement, FDA is publishing notice diseases; (2) a description of the
Maintaining a Data Bank of the proposed collection of purpose of the experimental drug; (3)
information set forth in this document. patient eligibility criteria; (4) the
AGENCY: Food and Drug Administration, With respect to the following location of clinical trial sites; and (5) a
HHS. collection of information, FDA invites point of contact for patients wanting to
ACTION: Notice. comments on these topics: (1) Whether enroll in the trial.
the proposed collection of information Senate 1789, ‘‘Best Pharmaceuticals
SUMMARY: The Food and Drug is necessary for the proper performance for Children Act’’ (Public Law 107–109)
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Administration (FDA) is announcing an of FDA’s functions, including whether (BPCA), established a new requirement
opportunity for public comment on the the information will have practical for the Clinical Trials Data Bank
proposed collection of certain utility; (2) the accuracy of FDA’s mandated by section 113 of FDAMA.
information by the agency. Under the estimate of the burden of the proposed Information submitted to the data bank
Paperwork Reduction Act of 1995 (the collection of information, including the must now include ‘‘a description of

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Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices 27141

whether, and through what procedure, the sponsor certifies to the Secretary of protocols per year are subject to
the manufacturer or sponsor of the Health and Human Services (the voluntary reporting.
investigation of a new drug will respond Secretary) that disclosure of the The Center for Biologics Evaluation
to requests for protocol exception, with information would substantially and Research (CBER) received 474 new
appropriate safeguards, for single- interfere with the timely enrollment of protocols in 2005. CBER anticipates that
patient and expanded protocol use of subjects in the investigation, unless the protocol submission rates will remain at
the new drug, particularly in children.’’ Secretary makes a determination to the or near this level in the near future. An
The guidance was updated on January contrary. estimated two-thirds1 of the new
27, 2004, to include a discussion of how protocols submitted to CBER are for
Description of Respondents: A
sponsors can fulfill the BPCA clinical trials involving a serious or life-
sponsor of a drug or biologic product threatening disease, and would be
As part of the resubmission process regulated by the agency under the subject to either voluntary or mandatory
for OMB approval, this information Federal Food, Drug, and Cosmetic Act reporting requirements under section
collection request (ICR) has been revised or section 351 of the Public Health 113 of the Modernization Act. Two-
to include the burden associated with Service Act (42 U.S.C. 262) who submits thirds of 474 new protocols per year is
new requirements imposed by the a clinical trial to test effectiveness of a 316 new protocols per year. An
Centers for Medicare and Medicaid drug or biologic product for a serious or estimated 50 percent1 of the new
Services (CMS). On September 19, 2000, life-threatening disease. protocols for serious or life-threatening
the Health Care Financing For the purposes of CMS, the diseases submitted to CBER are for
Administration (now CMS) respondents will be providers that are clinical trials involving assessments for
implemented a Clinical Trial Policy conducting or sponsoring clinical trials effectiveness. Fifty percent of 316
through the National Coverage that are seeking to have the clinical protocols per year is an estimated 158
Determination process. The Clinical costs of their studies reimbursed by new protocols per year subject to the
Trial Policy was developed in response Medicare. mandatory reporting requirements
to a June 7, 2000, executive under section 113 of the Modernization
Burden Estimate: The information
memorandum, issued by President Act. The remaining 316 new protocols
required under section 113(a) of the
Clinton, requiring Medicare to pay for per year are subject to voluntary
Modernization Act is currently
routine patient costs in clinical trials. reporting.
submitted to FDA under 21 CFR part The estimated total number of new
The original policy suggested that a
312, and this collection of information protocols for serious or life-threatening
registry be established into which
is approved under OMB Control diseases subject to mandatory reporting
studies meeting the criteria for coverage
Number 0910–0014 until May 31, 2009, requirements under section 113 of the
under the policy would be enrolled for
and, therefore, does not represent a new Modernization Act is 1,620 for CDER
administrative purposes. This registry
information collection requirement. plus 158 for CBER, or 1,778 new
was never established.
On July 10, 2006, CMS opened a Instead, preparation of submissions protocols per year. The remainder of
reconsideration of its national coverage under section 113 of the Modernization protocols submitted to CDER or CBER
determination on clinical trials. The Act involves extracting and reformatting will be subject to voluntary reporting,
purpose of the reconsideration is to information already submitted to FDA. including clinical trials not involving a
further refine the policy to rename it the Procedures (where and how) for the serious or life-threatening disease as
Clinical Research Policy (CRP) to actual submission of this information to well as trials in a serious or life-
address several ambiguities, including the Clinical Trials Data Bank are threatening disease but not involving
the link between the CRP and the addressed in the guidance. assessment of effectiveness. Therefore,
Coverage with Evidence Development The Center for Drug Evaluation and the total number of protocols (5,332)
concept, and the authority to allow the Research (CDER) received 4,858 new minus the protocols subject to
agency to pay for the costs of limited protocols in 2005. CDER anticipates that mandatory reporting requirements
investigational items. One requirement protocol submission rates will remain at (1,778) will be subject to voluntary
to qualify for coverage of clinical costs or near this level in the near future. Of reporting, or 3,554 protocols.
under the proposed policy is that the these new protocols, an estimated two- Our total burden estimate includes
study must be enrolled in the NLM thirds1 are for serious or life-threatening multi-center studies and accounts for
Clinical Trials Data Bank. diseases and would be subject to either the quality control review of the data
voluntary or mandatory reporting before it is submitted to the data bank.
Voluntary Submissions requirements under section 113 of the The number of IND amendments
Section 113 of the Modernization Act Modernization Act. Two-thirds of 4,858 submitted in 2005 for protocol changes
also specifies that sponsors may protocols per year is 3,239 new (e.g., changes in eligibility criteria) was
voluntarily submit information protocols per year. An estimated 50 7,597 for CDER and 855 for CBER. The
pertaining to results of clinical trials, percent1 of the new protocols for serious number of IND amendments submitted
including information on potential or life-threatening diseases submitted to in 2005 for new investigators was
toxicities or adverse effects associated CDER are for clinical trials involving 11,287 for CDER and 532 for CBER. The
with the use or administration of the assessment for effectiveness, and are number of protocol changes and new
investigational treatment. Sponsors may subject to the mandatory reporting investigators was apportioned
also voluntarily submit studies that are requirements under section 113 of the proportionally between mandatory and
not trials to test effectiveness, or not for Modernization Act. Fifty percent of voluntary submissions. We recognize
serious or life-threatening diseases, to 3,239 protocols per year is 1,620 new that single submissions may include
the Clinical Trials Data Bank. information about multiple sites.
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protocols per year subject to mandatory

reporting. The remaining 3,238 new Generally, there is no submission to
Certifications FDA when an individual study site is no
Section 113 of the Modernization Act 1 Estimate obtained from a review of 2,062 longer recruiting study subjects. For this
specifies that the data bank will not protocols submitted to CDER between January 1, analysis, we assumed that the number of
include information relating to a trial if 2002, and September 30, 2002. study sites closed each year is similar to

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27142 Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices

the number of new investigator Trials Data Bank, FDA estimated that hourly burden will continue to
amendments received by FDA (11,287 approximately 4.6 hours on average decrease.
CDER and 532 CBER). would be needed per response. The A sponsor of a study subject to the
Generally, there is no submission to estimate incorporates 2.6 hours for data requirements of section 113 of the
FDA when the study is closed to extraction and 2.0 hours for reformatting Modernization Act will have the option
enrollment. We estimate the number of based on data collected from of submitting data under that section or
protocols closed to enrollment each year organizations currently submitting certifying to the Secretary that
is similar to the number of new protocols to the Clinical Trials Data disclosure of information for a specific
protocols submitted (4,858 CDER and Bank. We considered quality control protocol would substantially interfere
474 CBER). issues when developing the current with the timely enrollment of subjects
The hours per response is the burden estimates of 2.6 hours for data in the clinical investigation. FDA has no
estimated number of hours that a
extraction and the 2.0 hours estimated means to accurately predict the
respondent would spend preparing the
for reformatting. Additionally, the proportion of protocols subject to the
information to be submitted under
Internet-based data entry system requirements of section 113 of the
section 113(a) of the Modernization Act,
developed by NIH incorporates features Modernization Act that will be subject
including the time it takes to extract and
that further decrease the sponsor’s time to a certification submission. To date,
reformat the information. FDA has been
advised that some sponsors lack requirements for quality control no certifications have been received. It
information system capabilities enabling procedures. The Clinical Trials Data is anticipated that the burden associated
efficient collection of company-wide Bank was set up to receive protocol with such certification will be
information on clinical trials subject to information transmitted electronically comparable to that associated with
reporting requirements under section by sponsors. Approximately 10 percent submission of data regarding a protocol.
113(a) of the Modernization Act. The of sponsors electronically transmit Therefore, the overall burden is
estimation of burden under section information to the Clinical Trials Data anticipated to be the same, regardless of
113(a) reflects the relative inefficiency Bank. If the sponsor chooses to whether the sponsor chooses data
of this process for these firms. manually enter the protocol submission or certification for
Based on its experience reviewing information, the data entry system nonsubmission. Table 1 of this
INDs, consideration of the information allows it to be entered in a uniform and document reflects the estimate of this
in the previous paragraphs, and further efficient manner primarily through pull- total burden.
consultation with sponsors who submit down menus. As sponsors’ familiarity FDA estimates the burden of this
protocol information to the Clinical with the data entry system increases, the collection of information as follows:


Recruitment Protocol New Total Hours per
New Protocols Site Closed Total Hours
Complete Changes Investigators Responses Response

CDER (mandatory) 1,620 1,620 2,507 3,725 13,197 4.6 60,706

CBER (mandatory) 158 158 282 176 950 4.6 4,370

CDER (voluntary) 3,238 3,238 5,090 7,562 26,690 4.6 122,774

CDER (voluntary) 316 316 573 356 1,917 4.6 8,818

Total 196,668
1There are no capital costs or operation and maintenance costs associated with this collection of information.

CMS Burden Estimate: study phase was applied to each of the hours) accurately reflects the total
The burden associated with CMS’ three separate searches by type of study. burden associated with this information
requirements is the time and effort The following number of studies by collection request. We recognize that
necessary for the provider to extract the study type, including trials no longer companies who are less familiar with
data elements from the study protocol recruiting was 562 for diagnosis, 164 for the data entry system and the Clinical
and reformatting and entering the cancers and other neoplasms, and 19 for Trials Data Bank will require greater
information into the data bank. We devices. In determining the total than 4.6 hours per response. However,
estimate that approximately 745 clinical number of hours requested, the CMS as sponsor familiarity with the system
research studies will register on the estimate uses the same assumptions increases, the hourly estimate will
NLM data bank. The number was used by the FDA to estimate its total decrease.
derived from a search of the database on number of burden hours. Therefore, the
September 1, 2006 restricting the search total annual burden associated with this Dated: May 8, 2007.
by age (e.g., > 65 years of age); sponsor requirement is 27,480 hours (5,974 Jeffrey Shuren,
(e.g., NIH, industry, other federal responses x 4.6 hours per response). Assistant Commissioner for Policy.
agency, university/organization); Phase We believe the combined estimate of
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[FR Doc. E7–9221 Filed 5–11–07; 8:45 am]

II, III or IV; and by type of study (e.g., burden attributable to FDA and CMS BILLING CODE 4160–01–S
cancers and other neoplasms, diagnosis, requirements, 224,148 burden hours
and devices). The age, sponsor, and (196,668 burden hours + 27,480 burden

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