Electronic Distribution of Prescribing Information for Prescription Drug Products; Reopening of Comment Period, 59536-59537 [E7-20759]
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59536
Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents. Consideration will be
given to comments and suggestions
submitted within 60 days of this
publication.
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: October 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20756 Filed 10–19–07; 8:45 am]
BILLING CODE 4160–01–S
Dated: October 10, 2007.
Brendan C. Kelly,
Reports Clearance Officer.
[FR Doc. 07–5176 Filed 10–19–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4184–01–M
[Docket No. 2007N–0114]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Distribution of Prescribing
Information for Prescription Drug
Products; Reopening of Comment
Period
Food and Drug Administration
Food and Drug Administration
AGENCY:
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Experimental Evaluation of Variations
in Content and Format of the Brief
Summary in Direct-to-Consumer Print
Advertisements for Prescription Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Experimental Evaluation of Variations
in Content and Format of the Brief
Summary in Direct-to-Consumer (DTC)
Print Advertisements for Prescription
Drugs’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4816.
In the
Federal Register of March 14, 2007 (72
FR 11889), 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 0910–0611. The
approval expires on October 31, 2010. A
copy of the supporting statement for this
information collection is available on
ebenthall on PRODPC61 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:02 Oct 19, 2007
Food and Drug Administration,
HHS.
[Docket No. 2006N–0133]
Jkt 214001
Notice; reopening of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is reopening to
December 6, 2007 the comment period
for the notice that published in the
Federal Register of April 2, 2007 (72 FR
15701); this notice was related to the
public hearing of April 27, 2007,
concerning the electronic distribution of
FDA-approved prescribing information
currently contained in the package
insert (PI) for prescription drug and
biological products. FDA is reopening
the comment period for the sole purpose
of inviting interested persons to submit
comments on the concept of electronic
distribution of FDA-approved
prescribing information currently
contained in the PI for prescription
animal drug products.
DATES: Submit written or electronic
comments by December 6, 2007.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Erik
Mettler, Office of Policy (HF–11), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
3360, Erik.Mettler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register notice of April
2, 2007 (72 FR 15701), FDA published
a notice of public hearing concerning
the concept of the electronic
distribution of PIs for human
prescription drugs and biological
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
products and solicited relevant
information and comments on this
concept. The purpose was to garner
views and information on the feasibility
of establishing an efficient process for
industry to electronically distribute
prescribing information to dispensers.
The PIs with prescribing information
accompany prescription human drugs to
meet the requirement that ‘‘labeling on
or within the package from which the
drug is to be dispensed bears adequate
information for its use * * *’’ (21 CFR
201.100(c)(1)). For additional
information, see the April 2, 2007,
notice ( 72 FR 15701).
Currently, the PI contains the
prescribing information for the safe and
effective use of the product in the form
of a paper leaflet. Although the
information in the PI is a valuable
resource, it is often not readily
accessible when a healthcare provider
who has not physically received the
drug makes a treatment decision or
discusses treatments with a patient.
Additionally, the PI may not contain the
most current information, because the PI
accompanying the drug’s distribution
may have been printed and distributed
prior to more recent labeling changes.
Accordingly, with technological
advances in the electronic transmission
of information, we are considering how
prescribing information could be more
effectively disseminated.
FDA is reopening the comment period
for the sole purpose of inviting
interested persons to submit comments
addressing a number of questions
regarding the current use of package
inserts for animal drug products and
those logistical issues associated with
electronic distribution of such
prescribing information for animal drug
products. The previous request for
comments was limited to human drugs
and biologics. As with prescription
human drugs, the PIs with prescribing
information accompany prescription
animal drugs to meet the requirement
that ‘‘labeling on or within the package
from which the drug is to be dispensed
bears adequate information for its use
* * *’’ (21 CFR 201.105(c)(1)). FDA
approves the prescribing information as
part of both human and animal drug
labeling in the drug application. The
request for comment is to gain a better
understanding of how PIs for animal
drugs are currently used by healthcare
entities as we consider new approaches
for the dissemination of labeling
information.
II. Issues for Discussion
FDA is specifically interested in
receiving comments on the following
questions and any other pertinent
E:\FR\FM\22OCN1.SGM
22OCN1
Federal Register / Vol. 72, No. 203 / Monday, October 22, 2007 / Notices
information related to the electronic
distribution of the prescribing
information for animals.
A. General
(1) Currently, who uses and benefits
from the prescribing information?
(2) How can electronic distribution
and access of the prescribing
information be accomplished?
(3) Would electronic distribution and
access of the prescribing information
improve the public health?
(4) Would electronic distribution and
access of prescribing information
improve prescribing habits? If so, how?
(5) How might we ensure that changes
in the distribution and access of the
prescribing information will not
negatively affect the current users?
(6) Would an increase in electronic
access to prescribing information affect
prescribers, pharmacists, clients and
patients? If so, how?
(7) Are there any issues particular to
the prescribing information for animal
drugs that are dissimilar or distinct from
those associated with human drugs and
that might affect the feasibility of
electronic distribution of labeling?
ebenthall on PRODPC61 with NOTICES
B. Logistics
(1) Generally and without focusing on
vendor-specific methods, how can
electronic distribution of prescribing
information be accomplished?
(2) What are the costs associated with
the successful implementation of
electronic distribution and access to
prescribing information, including
startup and maintenance expenses?
Please breakdown costs per healthcare
sector.
(3) Is the technology and
infrastructure currently available to
accomplish electronic distribution and
access? If so, what is available? If not,
what is needed?
(4) What are other potential barriers to
accomplishing the electronic
prescribing information?
(5) How can we ensure that electronic
prescribing information is accessible to
those who need the information?
(6) How do we meet the needs of
those who do not have electronic
capability?
(7) In case of emergency or when a
computer system is down, what might
be the backup?
(8) How should electronically
disseminated prescribing information be
regularly updated and remain current?
(9) What are the roles for the involved
parties (manufacturers, third-parties,
health professionals, FDA, and
consumers)?
(10) Should all products have
electronic prescribing information or are
VerDate Aug<31>2005
15:02 Oct 19, 2007
Jkt 214001
there some products or classes of
products that should continue to have
paper prescribing information
accompany the product?
(11) If electronic prescribing
information were to be used instead of
paper inserts, then how should
electronic prescribing information be
implemented? Should electronic
prescribing information be phased in? If
so, over what time period? Which
products should use electronic
prescribing information first?
III. How to Submit Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments to https://www.fda.gov/
dockets/ecomments or two paper copies
of any mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number at the heading of this
document. Received comments may be
seen in the office above between 9 a.m.
and 4 p .m., Monday through Friday.
Dated: October 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20759 Filed 10–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
HRSA’s Bureau of Primary Health Care
(BPHC) Awards Unsolicited Proposal
for Cooperative Agreement to the
National Network for Oral Health
Access
Health Resources and Services
Administration (HRSA), HHS.
ACTION: HRSA’s Bureau of Primary
Health Care (BPHC) announces the
award of an unsolicited proposal from
the National Network for Oral Health
Access (NNOHA) to establish a
cooperative agreement with HRSA
providing services and resources to
support the Health Center Program’s
oral health providers serving the oral
health needs of underserved
populations.
AGENCY:
Recipient: National Network for Oral
Health Access, Ft. Lupton, Colorado.
Purpose of the award: Cooperative
Agreement with HRSA to provide
services and resources to support the
Health Center Program’s oral health
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
59537
providers serving the oral health needs
of underserved populations.
Amount of award: $200,000.
Project period: 1 year; September 25,
2007, to September 24, 2008.
SUMMARY: HRSA’s BPHC has performed
a formal review of an unsolicited
proposal from NNOHA to establish a
cooperative agreement with HRSA to
provide services and resources to
support the Health Center Program’s
oral health providers serving the oral
health needs of underserved
populations. BPHC has reviewed the
proposal and has determined that it has
merit. This request is of strategic
importance to the Department of Health
and Human Services (HHS) and is time
critical. Funding for the proposed
activities will promote access to oral
health services as an integral component
of primary health care, improve the
quality of those services provided, and
sustain the forward motion of
departmental priorities in this area.
The Cooperative Agreement with
NNOHA will have a project period of 1
year with funding at $200,000. The
funds will support selected activities
described in the application to develop
a national infrastructure to support
improved access to oral health care, and
improved quality and workforce
development for the growing number of
health center oral health programs.
The key anticipated outcomes of the
proposed cooperative agreement are as
follows:
• The development of oral health
clinical quality infrastructure to support
HRSA in achieving its goal of improved
quality of care;
• The development of a recruitment
and retention strategy to address dentist
and dental hygienist vacancies,
including National Health Service Corps
dentist and dental hygiene openings;
and
• NNOHA will work in collaboration
with HRSA to implement a strategy to
integrate oral health as it moves all of
its programs forward in Health
Information Technology to assure that
oral health strategies are included.
There is a strategic importance of
access to oral health as part of the
primary care services supported by
BPHC’s Health Center Program. The
Health Center Program has had
significant growth as part of the
President’s Health Center Initiative. The
number of patients seen by the Health
Center Program has increased by 90
percent. Health centers have reported
significant challenges recruiting and
retaining oral health providers.
Consequently, HRSA has determined
that the scope of this proposal is
immediate and necessary. The proposed
E:\FR\FM\22OCN1.SGM
22OCN1
]]>Agencies
[Federal Register Volume 72, Number 203 (Monday, October 22, 2007)]
[Notices]
[Pages 59536-59537]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0114]
Electronic Distribution of Prescribing Information for
Prescription Drug Products; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is reopening to
December 6, 2007 the comment period for the notice that published in
the Federal Register of April 2, 2007 (72 FR 15701); this notice was
related to the public hearing of April 27, 2007, concerning the
electronic distribution of FDA-approved prescribing information
currently contained in the package insert (PI) for prescription drug
and biological products. FDA is reopening the comment period for the
sole purpose of inviting interested persons to submit comments on the
concept of electronic distribution of FDA-approved prescribing
information currently contained in the PI for prescription animal drug
products.
DATES: Submit written or electronic comments by December 6, 2007.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to either
https://www.fda.gov/dockets/ecomments or https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360, Erik.Mettler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register notice of April 2, 2007 (72 FR 15701), FDA
published a notice of public hearing concerning the concept of the
electronic distribution of PIs for human prescription drugs and
biological products and solicited relevant information and comments on
this concept. The purpose was to garner views and information on the
feasibility of establishing an efficient process for industry to
electronically distribute prescribing information to dispensers. The
PIs with prescribing information accompany prescription human drugs to
meet the requirement that ``labeling on or within the package from
which the drug is to be dispensed bears adequate information for its
use * * *'' (21 CFR 201.100(c)(1)). For additional information, see the
April 2, 2007, notice ( 72 FR 15701).
Currently, the PI contains the prescribing information for the safe
and effective use of the product in the form of a paper leaflet.
Although the information in the PI is a valuable resource, it is often
not readily accessible when a healthcare provider who has not
physically received the drug makes a treatment decision or discusses
treatments with a patient. Additionally, the PI may not contain the
most current information, because the PI accompanying the drug's
distribution may have been printed and distributed prior to more recent
labeling changes. Accordingly, with technological advances in the
electronic transmission of information, we are considering how
prescribing information could be more effectively disseminated.
FDA is reopening the comment period for the sole purpose of
inviting interested persons to submit comments addressing a number of
questions regarding the current use of package inserts for animal drug
products and those logistical issues associated with electronic
distribution of such prescribing information for animal drug products.
The previous request for comments was limited to human drugs and
biologics. As with prescription human drugs, the PIs with prescribing
information accompany prescription animal drugs to meet the requirement
that ``labeling on or within the package from which the drug is to be
dispensed bears adequate information for its use * * *'' (21 CFR
201.105(c)(1)). FDA approves the prescribing information as part of
both human and animal drug labeling in the drug application. The
request for comment is to gain a better understanding of how PIs for
animal drugs are currently used by healthcare entities as we consider
new approaches for the dissemination of labeling information.
II. Issues for Discussion
FDA is specifically interested in receiving comments on the
following questions and any other pertinent
[[Page 59537]]
information related to the electronic distribution of the prescribing
information for animals.
A. General
(1) Currently, who uses and benefits from the prescribing
information?
(2) How can electronic distribution and access of the prescribing
information be accomplished?
(3) Would electronic distribution and access of the prescribing
information improve the public health?
(4) Would electronic distribution and access of prescribing
information improve prescribing habits? If so, how?
(5) How might we ensure that changes in the distribution and access
of the prescribing information will not negatively affect the current
users?
(6) Would an increase in electronic access to prescribing
information affect prescribers, pharmacists, clients and patients? If
so, how?
(7) Are there any issues particular to the prescribing information
for animal drugs that are dissimilar or distinct from those associated
with human drugs and that might affect the feasibility of electronic
distribution of labeling?
B. Logistics
(1) Generally and without focusing on vendor-specific methods, how
can electronic distribution of prescribing information be accomplished?
(2) What are the costs associated with the successful
implementation of electronic distribution and access to prescribing
information, including startup and maintenance expenses? Please
breakdown costs per healthcare sector.
(3) Is the technology and infrastructure currently available to
accomplish electronic distribution and access? If so, what is
available? If not, what is needed?
(4) What are other potential barriers to accomplishing the
electronic prescribing information?
(5) How can we ensure that electronic prescribing information is
accessible to those who need the information?
(6) How do we meet the needs of those who do not have electronic
capability?
(7) In case of emergency or when a computer system is down, what
might be the backup?
(8) How should electronically disseminated prescribing information
be regularly updated and remain current?
(9) What are the roles for the involved parties (manufacturers,
third-parties, health professionals, FDA, and consumers)?
(10) Should all products have electronic prescribing information or
are there some products or classes of products that should continue to
have paper prescribing information accompany the product?
(11) If electronic prescribing information were to be used instead
of paper inserts, then how should electronic prescribing information be
implemented? Should electronic prescribing information be phased in? If
so, over what time period? Which products should use electronic
prescribing information first?
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments to https://www.fda.gov/
dockets/ecomments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number at the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p .m., Monday through Friday.
Dated: October 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20759 Filed 10-19-07; 8:45 am]
BILLING CODE 4160-01-S
