Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket, 65410-65411 [2014-26145]
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Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
there is adequate publicly available and
widely established evidence supporting
the claim, then the time to gather
supporting data will be minimal; if the
product is the first of its kind to make
a particular claim or the evidence
supporting the claim is less publicly
available or not widely established, then
gathering the appropriate scientific
evidence to substantiate the claim will
be more time consuming.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Claim type
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Widely known, established ..................................................
Pre-existing, not widely established ....................................
Novel ....................................................................................
667
667
667
1
1
1
667
667
667
44
120
120
29,348
80,040
80,040
Total ..............................................................................
........................
........................
........................
........................
189,428
rmajette on DSK3VPTVN1PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
We assume that it will take 44 hours
to assemble information needed to
substantiate a claim on a particular
dietary supplement when the claim is
widely known and established. We
believe it will take closer to 120 hours
to assemble supporting scientific
information when the claim is novel or
when the claim is pre-existing but the
scientific underpinnings of the claim are
not widely established. These are claims
that may be based on emerging science,
where conducting literature searches
and understanding the literature takes
time. It is also possible that references
for claims made for some dietary
ingredients or dietary supplements may
primarily be found in foreign journals
and in foreign languages or in the older,
classical literature where it is not
available on computerized literature
databases or in the major scientific
reference databases, such as the
National Library of Medicine’s literature
database, all of which increases the time
of obtaining substantiation.
In the Federal Register of January 6,
2000 (65 FR 1000), we published a final
rule on statements made for dietary
supplements concerning the effect of the
product on the structure or function of
the body. In that final rule, we estimated
that there were 29,000 dietary
supplement products marketed in the
United States (65 FR 1000 at 1045).
Assuming that the flow of new products
is 10 percent per year, then 2,900 new
dietary supplement products will come
on the market each year. The structure/
function final rule estimated that about
69 percent of dietary supplements have
a claim on their labels, most probably a
structure/function claim (65 FR 1000 at
1046). Therefore, we assume that
supplement manufacturers will need
time to assemble the evidence to
substantiate each of the 2,001 claims
(2,900 × 69 percent) made each year. If
we assume that the 2,001 claims are
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
equally likely to be pre-existing widely
established claims, novel claims, or preexisting claims that are not widely
established, then we can expect 667 of
each of these types of claims to be
substantiated per year. Table 1 of this
document shows that the annual burden
hours associated with assembling
evidence for claims is 189,428 (the sum
of 667 × 44 hours, 667 × 120 hours, and
667 × 120 hours).
Dated: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26142 Filed 11–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1698]
Food and Drug Administration
Activities for Patient Participation in
Medical Product Discussions;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; Establishment of docket;
Request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
establishment of a public docket for
comments on FDA activities performed
under the Food and Drug
Administration Safety and Innovation
Act (FDASIA), Patient Participation in
Medical Product Discussions. This
notice announces FDA’s intent to gather
input from stakeholders on strategies to
obtain the views of patients during the
medical product development process
and ways to consider patients’
perspectives during regulatory
discussions. This notice provides
background on ongoing patient
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
engagement activities, so that
stakeholders can consider both current
and new activities that involve patient
participation and perspectives during
medical product regulatory discussions.
DATES: Although FDA welcomes
comments at any time, to help FDA
address issues related to Patient
Participation in Medical Products
Discussions in a timely fashion,
comments should be submitted by
December 4, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Andrea Furia-Helms, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5319, Silver Spring,
MD 20993–0002, Andrea.Furia@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed
into law FDASIA (Pub. L. 112–144).
FDASIA expands the FDA’s authorities
and strengthens the Agency’s ability to
safeguard and advance public health in
several areas including increasing
stakeholder involvement in FDA
regulatory processes. Specifically,
section 1137 of FDASIA directs the
Secretary of HHS to ‘‘develop and
implement strategies to solicit the views
of patients during the medical product
development process and consider the
perspectives of patients during
regulatory discussions, including by—
(1) fostering participation of a patient
representative who may serve as a
special government employee in
E:\FR\FM\04NON1.SGM
04NON1
rmajette on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices
appropriate agency meetings with
medical product sponsors and
investigators; and (2) exploring means to
provide for identification of patient
representatives who do not have any, or
have minimal, financial interests in the
medical products industry.’’
FDA has formed an Agency-wide
working group to explore approaches
and procedures as well as to align
strategies across the Agency for patient
participation in accordance with the
statute. Involvement of the patient
community brings the unique
perspective of patients, family members,
caregivers, and patient advocates to the
decision-making processes of the FDA,
and FDA is currently using a variety of
tools to help ensure that the patient
community is involved in medical
product discussions to enhance benefitrisk assessment. FDA assesses the
benefit-risk of new drugs and certain
devices on a case-by-case basis. In this
assessment, FDA may consider, among
other things, the degree of unmet
medical need and the severity and
morbidity of the condition or disease
the drug or device is intended to treat
or diagnose. This approach has been
critical to increasing patient access to
new treatments for cancer, other serious
diseases, and rare diseases, where
existing therapies have been few and
limited in their effectiveness.
Currently, patient representatives can
serve as Special Government Employees
(SGEs) in order to participate as a
member of an FDA’s federal advisory
committee meeting about medical
products undergoing the FDA review
process for marketing approval and
other regulatory issues. Patient
representatives serve as committee
members on advisory committees
managed by the Office of the
Commissioner, Center for Drug
Evaluation and Research, Center for
Biologics Evaluation and Research, and
Center for Devices and Radiological
Health. SGE patient representatives may
also serve on special assignments to
provide feedback and perspective on
product reviews in progress. These SGE
activities are in addition to the many
other activities in which FDA obtains
patient perspectives, such as open
public hearings on specific diseases or
drug development issues, and as
speakers at FDA-sponsored conferences
and workshops.
FDASIA includes the reauthorization
of the Prescription Drug User Fee Act
(PDUFA) that provides FDA with the
necessary resources to maintain a
predictable and efficient review process
for human drug and biological products.
This is the fifth authorization of PDUFA
(otherwise known as ‘‘PDUFA V’’),
VerDate Sep<11>2014
15:39 Nov 03, 2014
Jkt 235001
which was, as directed by Congress,
developed in consultation with drug
industry representatives, patient and
consumer advocates, health care
professionals, and other public
stakeholders. Under PDUFA V, FDA
intends to conduct at least 20 public
meetings that aim to more
systematically gather patients’
perspectives on their conditions and
available therapies to treat those
conditions (Patient Focused Drug
Development). PDUFA V also includes
an initiative to enhance FDA’s review of
patient-reported outcome study
endpoints and endpoint assessment
tools.
FDASIA also includes the
reauthorization of the Medical Device
User Fee Act (MDUFA) that provides
FDA the necessary resources to increase
the efficiency of regulatory processes in
order to reduce the time it takes to bring
safe and effective medical devices to the
U.S. market. This third authorization of
MDUFA (otherwise known as ‘‘MDUFA
III’’), was a result of more than a year
of public input, negotiations with
industry representatives, and
discussions with patient and consumer
stakeholders. Under MDUFA III, FDA
has established the Patient Preference
Initiative to provide the information,
guidance, and framework necessary to
incorporate patient preferences on the
benefit-risk tradeoffs of medical devices
into the full spectrum of medical device
regulatory processes and to inform
medical device innovation by the larger
medical device community. In the
process, the initiative aims to advance
the science of measuring medical device
preferences of patients, caregivers, and
providers. Once the Patient Preference
Initiative helps to define or refine the
methods to measure patient preferences,
FDA intends to incorporate patient
views into the total product life cycle of
medical devices.
FDA is opening a docket for 30 days
to provide an opportunity for interested
stakeholders to submit comments on
‘‘strategies to solicit the views of
patients during the medical product
development process and consider the
perspectives of patients during
regulatory discussions’’ under section
1137 of FDASIA. FDA is interested in
comments on both current and new
activities that would involve patient
participation in regulatory discussions,
as well as comments on ways to assess
patient participation activities.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
65411
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26145 Filed 11–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
AGENCY:
ACTION:
Notice.
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
full certification under the Mandatory
Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
SUMMARY:
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65410-65411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1698]
Food and Drug Administration Activities for Patient Participation
in Medical Product Discussions; Establishment of a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; Establishment of docket; Request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a public docket for comments on FDA activities
performed under the Food and Drug Administration Safety and Innovation
Act (FDASIA), Patient Participation in Medical Product Discussions.
This notice announces FDA's intent to gather input from stakeholders on
strategies to obtain the views of patients during the medical product
development process and ways to consider patients' perspectives during
regulatory discussions. This notice provides background on ongoing
patient engagement activities, so that stakeholders can consider both
current and new activities that involve patient participation and
perspectives during medical product regulatory discussions.
DATES: Although FDA welcomes comments at any time, to help FDA address
issues related to Patient Participation in Medical Products Discussions
in a timely fashion, comments should be submitted by December 4, 2014.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Andrea Furia-Helms, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5319, Silver
Spring, MD 20993-0002, Andrea.Furia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed into law FDASIA (Pub. L. 112-
144). FDASIA expands the FDA's authorities and strengthens the Agency's
ability to safeguard and advance public health in several areas
including increasing stakeholder involvement in FDA regulatory
processes. Specifically, section 1137 of FDASIA directs the Secretary
of HHS to ``develop and implement strategies to solicit the views of
patients during the medical product development process and consider
the perspectives of patients during regulatory discussions, including
by--(1) fostering participation of a patient representative who may
serve as a special government employee in
[[Page 65411]]
appropriate agency meetings with medical product sponsors and
investigators; and (2) exploring means to provide for identification of
patient representatives who do not have any, or have minimal, financial
interests in the medical products industry.''
FDA has formed an Agency-wide working group to explore approaches
and procedures as well as to align strategies across the Agency for
patient participation in accordance with the statute. Involvement of
the patient community brings the unique perspective of patients, family
members, caregivers, and patient advocates to the decision-making
processes of the FDA, and FDA is currently using a variety of tools to
help ensure that the patient community is involved in medical product
discussions to enhance benefit-risk assessment. FDA assesses the
benefit-risk of new drugs and certain devices on a case-by-case basis.
In this assessment, FDA may consider, among other things, the degree of
unmet medical need and the severity and morbidity of the condition or
disease the drug or device is intended to treat or diagnose. This
approach has been critical to increasing patient access to new
treatments for cancer, other serious diseases, and rare diseases, where
existing therapies have been few and limited in their effectiveness.
Currently, patient representatives can serve as Special Government
Employees (SGEs) in order to participate as a member of an FDA's
federal advisory committee meeting about medical products undergoing
the FDA review process for marketing approval and other regulatory
issues. Patient representatives serve as committee members on advisory
committees managed by the Office of the Commissioner, Center for Drug
Evaluation and Research, Center for Biologics Evaluation and Research,
and Center for Devices and Radiological Health. SGE patient
representatives may also serve on special assignments to provide
feedback and perspective on product reviews in progress. These SGE
activities are in addition to the many other activities in which FDA
obtains patient perspectives, such as open public hearings on specific
diseases or drug development issues, and as speakers at FDA-sponsored
conferences and workshops.
FDASIA includes the reauthorization of the Prescription Drug User
Fee Act (PDUFA) that provides FDA with the necessary resources to
maintain a predictable and efficient review process for human drug and
biological products. This is the fifth authorization of PDUFA
(otherwise known as ``PDUFA V''), which was, as directed by Congress,
developed in consultation with drug industry representatives, patient
and consumer advocates, health care professionals, and other public
stakeholders. Under PDUFA V, FDA intends to conduct at least 20 public
meetings that aim to more systematically gather patients' perspectives
on their conditions and available therapies to treat those conditions
(Patient Focused Drug Development). PDUFA V also includes an initiative
to enhance FDA's review of patient-reported outcome study endpoints and
endpoint assessment tools.
FDASIA also includes the reauthorization of the Medical Device User
Fee Act (MDUFA) that provides FDA the necessary resources to increase
the efficiency of regulatory processes in order to reduce the time it
takes to bring safe and effective medical devices to the U.S. market.
This third authorization of MDUFA (otherwise known as ``MDUFA III''),
was a result of more than a year of public input, negotiations with
industry representatives, and discussions with patient and consumer
stakeholders. Under MDUFA III, FDA has established the Patient
Preference Initiative to provide the information, guidance, and
framework necessary to incorporate patient preferences on the benefit-
risk tradeoffs of medical devices into the full spectrum of medical
device regulatory processes and to inform medical device innovation by
the larger medical device community. In the process, the initiative
aims to advance the science of measuring medical device preferences of
patients, caregivers, and providers. Once the Patient Preference
Initiative helps to define or refine the methods to measure patient
preferences, FDA intends to incorporate patient views into the total
product life cycle of medical devices.
FDA is opening a docket for 30 days to provide an opportunity for
interested stakeholders to submit comments on ``strategies to solicit
the views of patients during the medical product development process
and consider the perspectives of patients during regulatory
discussions'' under section 1137 of FDASIA. FDA is interested in
comments on both current and new activities that would involve patient
participation in regulatory discussions, as well as comments on ways to
assess patient participation activities.
II. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26145 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P
