Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products, 39628-39629 [E7-14015]

Download as PDF 39628 ACTION: Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Threshold of Regulation for Substances Used in Food-Contact Articles’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. In the Federal Register of March 22, 2007 (72 FR 13499), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0298. The approval expires on June 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–14014 Filed 7–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0283] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians’ Perceptions of the Impact of Early Risk Communication About Medical Products AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with NOTICES 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. VerDate Aug<31>2005 15:31 Jul 18, 2007 Fax written comments on the collection of information by August 20, 2007. 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, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number ‘‘0910–NEW’’ and title, ‘‘FDA Survey of Physicians’ Perceptions of the Impact of Early Risk Communication about Medical Products.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 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. DATES: Jkt 211001 FDA Survey of Physicians’ Perceptions of the Impact of Early Risk Communication about Medical Products (OMB Control Number 0910– NEW) The authority for FDA to collect the information derives from the FDA Commissioner’s authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA engages in a number of communication activities to inform health care providers about new risks of regulated medical products, including prescription drugs, biologics, and medical devices (for example, pacemakers, implantable cardiac defibrillators, contact lenses, infusion pumps). More recently, FDA’s communication activities have also included the general public. Activities include, but are not limited to, communications in medical journals, through the press (press releases, public health advisories), letters to health care providers sent out in cooperation with product manufacturers, and notifications and information sheets about recalls, withdrawals, and new product safety information on FDA’s Internet site. Extensive publicity regarding serious side effects from certain commonly used prescription drugs, as well as certain implantable medical devices, has spurred public pressure to make risk PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 information available sooner. In opposition to such public pressures, however, at least some prescribers and medical societies have suggested that early disclosure of potential side effects (emerging risks) may have unintended negative effects on patient care. For FDA to plan informed programmatic communication activities we need better empirical data about the impact of disseminating emerging risk information on providers and patient care. In addition, only limited research addresses specific barriers to physicians reporting patient adverse events either to FDA or product manufacturers. Further, we have no data evaluating FDA’s efforts to improve reporting. Given differing perspectives on the value and timing of providing risk information to medical experts and the public at large, FDA believes it is important to assess how well it is communicating with physicians--the health care provider group with primary responsibility for deciding whether to use medical products to address patient problems. This information is critical both to plan programmatic communication activities and to improve the effectiveness of our reporting systems. Therefore, FDA plans to conduct a survey of a nationally representative group of physicians about these issues. The survey will collect information from respondents through computerassisted telephone interviews conducted by experienced interviewers. FDA expects to have a final sample of 900 physicians, broken down approximately half and half between primary care practitioners (general practice, family practice, general internal medicine, and pediatricians) and specialists. The physician specialty groups identified for inclusion in the survey are office-based allergists, dermatologists, endocrinologists, nephrologists, certain oncologists, ophthalmologists, certain surgeons, psychiatrists, pulmonologists and rheumatologists. These groups were chosen to provide a reasonable crosssection of specialists who use both drugs and medical devices that might have been the focus of relatively recent publicity concerning emerging risk information. Procedures will be used to ensure production of a sample of physicians that is reasonably representative of the population within the United States. The design of the interview questions will be guided by the results of a series of 6 physician focus groups. The interview will take approximately 15 minutes to administer. Key information to be collected includes the following topics: E:\FR\FM\19JYN1.SGM 19JYN1 39629 Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices 1. The impact on physicians, their patients, and their practices of the disclosure of still uncertain, emerging risks associated with medical products. 2. How physicians currently receive and ideally would like to receive new risk information about medical products (for example, at what level of certainty regarding causality and through what communication channels). 3. How physicians perceive the trustworthiness of FDA and other potential sources of risk information, including product sponsors, medical societies, and the media. 4. What FDA might do to increase the likelihood that respondents will report to FDA or to manufacturers serious patient reactions that might be side effects of using medical products. In the Federal Register of July 31, 2006 (71 FR 43200), FDA published a 60-day notice requesting public comment on the information collection provisions. Comments were received from five public entities consisting of two corporations and three associations. Comments supported FDA’s belief in the value of conducting the survey. None of the comments addressed specific survey questions. FDA agrees with the comments concerning the study methodology. • Questions should be clear and not leading or ambiguous. • FDA should conduct pre-tests. • The sample size will be sufficient to provide statistically relevant information for the two stratified segments of physicians and the combination of these segments. After carefully considering them, FDA determined that other comments would require changes that would reduce the utility of study results by diluting the study’s focus, omitting important topic areas, or making the questionnaire excessively long and thereby reducing response rates. These comments included the following: • Including other health care providers ‘‘who prescribe drugs.’’ • Getting more detail about particular source categories. • Omitting questions about how respondents report adverse events or product problems. FDA agreed with the value of adding some questions that ask about the inclusion of other information, including benefits, in communications about newly emerging product risks. FDA also received feedback from experts in the fields of risk communication and health literacy on the study and the proposed questionnaire at an ‘‘Effective Risk Communication’’ Think Tank Workshop. FDA revised the survey questionnaire in response to this feedback, the feedback received through the public comments, and eight cognitive interviews conducted in May 2007. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 27 (Pretests) 1 27 .3 8.1 1,000 (Screener) 1 1,000 .025 25.0 900 (Survey) 1 900 .25 225.0 Total 1 There 258.1 are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on FDA’s and the contractor’s experience with previous surveys. The respondents are divided into two groups: Primary care physicians and specialist physicians. We are basing this estimate on 90 percent of the screened physicians being eligible to participate in the survey. Prior to administering the survey with the entire sample, FDA plans to conduct pretests with up to 27 physicians; these are meant to evaluate the clarity and consistency of the survey questionnaire and interview protocol. Dated: July 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–14015 Filed 7–18–07; 8:45 am] cprice-sewell on PROD1PC66 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 15:31 Jul 18, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P–0052] Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug Evaluation and Research (HFD–7), Food PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved under a new drug application (NDA). ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal SUPPLEMENTARY INFORMATION: E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39628-39629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14015]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0283]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; FDA Survey of
Physicians' Perceptions of the Impact of Early Risk Communication About
Medical Products

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 August
20, 2007.

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, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number ``0910-NEW'' and
title, ``FDA Survey of Physicians' Perceptions of the Impact of Early
Risk Communication about Medical Products.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

FDA Survey of Physicians' Perceptions of the Impact of Early Risk
Communication about Medical Products (OMB Control Number 0910-NEW)

The authority for FDA to collect the information derives from the
FDA Commissioner's authority, as specified in section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
FDA engages in a number of communication activities to inform
health care providers about new risks of regulated medical products,
including prescription drugs, biologics, and medical devices (for
example, pacemakers, implantable cardiac defibrillators, contact
lenses, infusion pumps). More recently, FDA's communication activities
have also included the general public. Activities include, but are not
limited to, communications in medical journals, through the press
(press releases, public health advisories), letters to health care
providers sent out in cooperation with product manufacturers, and
notifications and information sheets about recalls, withdrawals, and
new product safety information on FDA's Internet site.
Extensive publicity regarding serious side effects from certain
commonly used prescription drugs, as well as certain implantable
medical devices, has spurred public pressure to make risk information
available sooner. In opposition to such public pressures, however, at
least some prescribers and medical societies have suggested that early
disclosure of potential side effects (emerging risks) may have
unintended negative effects on patient care. For FDA to plan informed
programmatic communication activities we need better empirical data
about the impact of disseminating emerging risk information on
providers and patient care. In addition, only limited research
addresses specific barriers to physicians reporting patient adverse
events either to FDA or product manufacturers. Further, we have no data
evaluating FDA's efforts to improve reporting.
Given differing perspectives on the value and timing of providing
risk information to medical experts and the public at large, FDA
believes it is important to assess how well it is communicating with
physicians--the health care provider group with primary responsibility
for deciding whether to use medical products to address patient
problems. This information is critical both to plan programmatic
communication activities and to improve the effectiveness of our
reporting systems. Therefore, FDA plans to conduct a survey of a
nationally representative group of physicians about these issues.
The survey will collect information from respondents through
computer-assisted telephone interviews conducted by experienced
interviewers. FDA expects to have a final sample of 900 physicians,
broken down approximately half and half between primary care
practitioners (general practice, family practice, general internal
medicine, and pediatricians) and specialists. The physician specialty
groups identified for inclusion in the survey are office-based
allergists, dermatologists, endocrinologists, nephrologists, certain
oncologists, ophthalmologists, certain surgeons, psychiatrists,
pulmonologists and rheumatologists. These groups were chosen to provide
a reasonable cross-section of specialists who use both drugs and
medical devices that might have been the focus of relatively recent
publicity concerning emerging risk information. Procedures will be used
to ensure production of a sample of physicians that is reasonably
representative of the population within the United States. The design
of the interview questions will be guided by the results of a series of
6 physician focus groups. The interview will take approximately 15
minutes to administer.
Key information to be collected includes the following topics:

[[Page 39629]]

1. The impact on physicians, their patients, and their practices of
the disclosure of still uncertain, emerging risks associated with
medical products.
2. How physicians currently receive and ideally would like to
receive new risk information about medical products (for example, at
what level of certainty regarding causality and through what
communication channels).
3. How physicians perceive the trustworthiness of FDA and other
potential sources of risk information, including product sponsors,
medical societies, and the media.
4. What FDA might do to increase the likelihood that respondents
will report to FDA or to manufacturers serious patient reactions that
might be side effects of using medical products.
In the Federal Register of July 31, 2006 (71 FR 43200), FDA
published a 60-day notice requesting public comment on the information
collection provisions. Comments were received from five public entities
consisting of two corporations and three associations. Comments
supported FDA's belief in the value of conducting the survey. None of
the comments addressed specific survey questions. FDA agrees with the
comments concerning the study methodology.
Questions should be clear and not leading or ambiguous.
FDA should conduct pre-tests.
The sample size will be sufficient to provide
statistically relevant information for the two stratified segments of
physicians and the combination of these segments.
After carefully considering them, FDA determined that other
comments would require changes that would reduce the utility of study
results by diluting the study's focus, omitting important topic areas,
or making the questionnaire excessively long and thereby reducing
response rates. These comments included the following:
Including other health care providers ``who prescribe
drugs.''
Getting more detail about particular source categories.
Omitting questions about how respondents report adverse
events or product problems.
FDA agreed with the value of adding some questions that ask about
the inclusion of other information, including benefits, in
communications about newly emerging product risks.
FDA also received feedback from experts in the fields of risk
communication and health literacy on the study and the proposed
questionnaire at an ``Effective Risk Communication'' Think Tank
Workshop. FDA revised the survey questionnaire in response to this
feedback, the feedback received through the public comments, and eight
cognitive interviews conducted in May 2007.

Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
27 (Pretests) 1 27 .3 8.1
----------------------------------------------------------------------------------------------------------------
1,000 (Screener) 1 1,000 .025 25.0
----------------------------------------------------------------------------------------------------------------
900 (Survey) 1 900 .25 225.0
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. 258.1
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

These estimates are based on FDA's and the contractor's experience
with previous surveys. The respondents are divided into two groups:
Primary care physicians and specialist physicians. We are basing this
estimate on 90 percent of the screened physicians being eligible to
participate in the survey.
Prior to administering the survey with the entire sample, FDA plans
to conduct pretests with up to 27 physicians; these are meant to
evaluate the clarity and consistency of the survey questionnaire and
interview protocol.

Dated: July 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14015 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S

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