Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting, 54794-54795 [2015-22949]
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54794
Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
November 10, 2015.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number _________, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
rmajette on DSK7SPTVN1PROD with NOTICES
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–855S Medicare Enrollment
Application—Durable Medical
Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) Suppliers
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
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Jkt 235001
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Dated: September 8, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
Information Collection
Drug Interactions With Hormonal
Contraceptives: Public Health and
Drug Development Implications; Public
Meeting
1. Type of Information Collection
Request: Revision of a currently
approved collection;
Title of Information Collection:
Medicare Enrollment Application—
Durable Medical Equipment,
Prosthetics, Orthotics and Supplies
(DMEPOS) Suppliers; Use: The primary
function of the CMS 855S Durable
Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS)
supplier enrollment application is to
gather information from a supplier that
tells us who it is, whether it meets
certain qualifications to be a health care
supplier, where it renders its services or
supplies, the identity of the owners of
the enrolling entity, and information
necessary to establish correct claims
payment.
The goal of this revision of the CMS
855S is to simplify and clarify the
current data collection and to remove
obsolete and/or redundant questions.
Grammar and spelling errors were
corrected. Limited informational text
has been added within the application
form and instructions in conjunction
with links to Web sites when greater
detail is needed by the supplier. To
clarify current data collection
differentiations and to be in sync with
accreditation coding, Section 3D
(‘‘Products and Services Furnished by
This Supplier’’) has been updated. This
revision does not offer any new material
data collection. Form Number: CMS–
855S (OMB Control Number: 0938–
1056); Frequency: Annually; Affected
Public: Private Sector (Business or other
for-profits and Not-for-profit
institutions); Number of Respondents:
31,915; Total Annual Responses:
31,915; Total Annual Hours: 36,842.
(For policy questions regarding this
collection contact Kim McPhillips at
410–786–5374.)
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[FR Doc. 2015–22944 Filed 9–10–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3156]
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Drug
Interactions with Hormonal
Contraceptives: Public Health and Drug
Development Implications’’ and an
opportunity for public comment on the
topic of drug interactions with
hormonal contraceptives (HCs). The
goal of this public meeting is to provide
an opportunity for FDA to seek input
from experts on the public health
concerns associated with use of HCs and
interacting drugs that might affect
efficacy and safety, pharmacokinetic
(PK)/pharmacodynamic (PD)
considerations in designing drug
interaction studies with HCs during
drug development, and approaches to
translating the results of drug
interaction information into informative
labeling and communication. The input
received may be used to refine FDA’s
thinking on HC drug interaction study
design and interpretation, and labeling
communication on drug interaction risk.
DATES: The public meeting will be held
on November 9, 2015, from 8:30 a.m. to
4:30 p.m. Individuals who wish to
attend the meeting in person or via Web
cast must register by October 9, 2015.
Please submit either electronic or
written comments by December 15,
2015, to receive consideration. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for the
meeting and submit electronic or
written comments.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, Section A of the
Great Room (Rm. 1503), Silver Spring,
MD 20993. Entrance for the public
SUMMARY:
E:\FR\FM\11SEN1.SGM
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Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
meeting participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
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.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/Drugs/
NewsEvents/ucm459342.htm.
FOR FURTHER INFORMATION CONTACT:
Christine Le, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3196, Silver Spring,
MD 20993, 301–796–2398, email:
Christine.Le@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
rmajette on DSK7SPTVN1PROD with NOTICES
I. Background
In general, HCs are highly effective in
preventing pregnancy when used
correctly. However, concomitant use of
other drugs may affect the safety and/or
efficacy of HCs due to drug interactions
affecting either blood levels (PK) and/or
physiologic effects (PD) of HC
components (e.g., estrogen and
progestins). Understanding drug
interaction potential of HCs and other
drugs is important when investigating
HC-related issues, and in the design and
conduct of clinical trials. Evolving
knowledge on drug interaction
mechanisms has led to new insights and
increased interest in the clinical
investigation of drug interactions with
HCs.
Historically, most drug interaction
studies conducted during drug
development with HCs have not had a
clearly stated rationale for the choice of
HCs being studied. Questions remain as
to whether the study results of specific
contraceptive steroids can be
extrapolated to other progestins or
estrogens or other dose strengths. The
choice of HC is important because
different progestins may have different
metabolic and/or transporter pathways
and safety profiles. Without a
mechanistic understanding of the
underlying drug-drug interaction (DDI)
mechanism, it is difficult to interpret
and extrapolate study results from one
HC to another.
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15:14 Sep 10, 2015
Jkt 235001
II. Discussion Topics for the Meeting
and for Public Comments
The public meeting on November 9,
2015, will include a discussion of the
following topics on which FDA is also
seeking public comment:
• Public health concerns associated
with use of HCs and interacting drugs
that might affect efficacy and safety.
• PK and PD considerations in
designing drug interaction studies with
HCs during drug development. Key
elements in designing a study include a
mechanistic understanding of potential
DDI mechanisms, the choice of
contraceptive products and their dose,
study population/duration, and proper
selection of a PK alone or PK–PD-based
drug interaction study approach.
• Drug interaction study result
interpretation and its potential impact
on guidance of HC use in women of
childbearing potential who are enrolled
in clinical trials for other therapeutic
agents during drug development.
• The current approach of translating
the results from drug interaction studies
into labeling recommendations and
opportunities to improve the
communication to healthcare providers.
• Research opportunities and tools for
investigating the safe use of HCs in the
presence of other drugs.
The input received may be used to
refine FDA’s thinking on the drug
interaction study design with HCs and
labeling communication of drug
interaction risks with HCs.
III. Meeting Attendance and
Participation
If you wish to attend these meetings,
register online at https://
www.surveymonkey.com/r/HCDDIMeeting. Please register by October
9, 2015. Those who are unable to attend
the meetings in person can register to
view a live Web cast of the meetings.
You will be asked to indicate in your
registration whether you plan to attend
in person or via the Web cast. Your
registration should also contain your
complete contact information, including
name, title, affiliation, address, email
address, and phone number.
Seating will be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meetings will be based on space
availability. If you need special
accommodations because of disability,
please contact Christine Le (see FOR
PO 00000
Frm 00034
Fmt 4703
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54795
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
FDA will hold an open public
comment period during the November
9, 2015, public meeting to give the
public an opportunity to comment.
Registration for open public comment
will occur at the registration desk on the
day of the meeting on a first-come, firstserved basis.
IV. Comments
Regardless of whether you attend this
meeting, you can submit electronic or
written comments, including responses
to the public docket (see ADDRESS
above), by December 15, 2015. 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.
V. Transcripts
Transcripts for the November 9, 2015,
meeting will be posted, when available,
at https://www.fda.gov/Drugs/
NewsEvents/ucm459342.htm.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22949 Filed 9–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting of the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (the
Advisory Council) is scheduled for
September 29, 2015, from 9:00 a.m. to
5:00 p.m. ET. The meeting will be open
to the public; a public comment session
will be held during the meeting. Preregistration is required for members of
the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should email CARB@hhs.gov.
Registration information is available on
the Web site https://www.hhs.gov/ash/
SUMMARY:
E:\FR\FM\11SEN1.SGM
11SEN1
]]>Agencies
[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Notices]
[Pages 54794-54795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22949]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3156]
Drug Interactions With Hormonal Contraceptives: Public Health and
Drug Development Implications; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Drug Interactions with Hormonal Contraceptives:
Public Health and Drug Development Implications'' and an opportunity
for public comment on the topic of drug interactions with hormonal
contraceptives (HCs). The goal of this public meeting is to provide an
opportunity for FDA to seek input from experts on the public health
concerns associated with use of HCs and interacting drugs that might
affect efficacy and safety, pharmacokinetic (PK)/pharmacodynamic (PD)
considerations in designing drug interaction studies with HCs during
drug development, and approaches to translating the results of drug
interaction information into informative labeling and communication.
The input received may be used to refine FDA's thinking on HC drug
interaction study design and interpretation, and labeling communication
on drug interaction risk.
DATES: The public meeting will be held on November 9, 2015, from 8:30
a.m. to 4:30 p.m. Individuals who wish to attend the meeting in person
or via Web cast must register by October 9, 2015. Please submit either
electronic or written comments by December 15, 2015, to receive
consideration. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting and submit electronic or
written comments.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, Section A of the Great
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
[[Page 54795]]
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For more
information on parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/Drugs/NewsEvents/ucm459342.htm.
FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3196, Silver Spring, MD 20993, 301-796-
2398, email: Christine.Le@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In general, HCs are highly effective in preventing pregnancy when
used correctly. However, concomitant use of other drugs may affect the
safety and/or efficacy of HCs due to drug interactions affecting either
blood levels (PK) and/or physiologic effects (PD) of HC components
(e.g., estrogen and progestins). Understanding drug interaction
potential of HCs and other drugs is important when investigating HC-
related issues, and in the design and conduct of clinical trials.
Evolving knowledge on drug interaction mechanisms has led to new
insights and increased interest in the clinical investigation of drug
interactions with HCs.
Historically, most drug interaction studies conducted during drug
development with HCs have not had a clearly stated rationale for the
choice of HCs being studied. Questions remain as to whether the study
results of specific contraceptive steroids can be extrapolated to other
progestins or estrogens or other dose strengths. The choice of HC is
important because different progestins may have different metabolic
and/or transporter pathways and safety profiles. Without a mechanistic
understanding of the underlying drug-drug interaction (DDI) mechanism,
it is difficult to interpret and extrapolate study results from one HC
to another.
II. Discussion Topics for the Meeting and for Public Comments
The public meeting on November 9, 2015, will include a discussion
of the following topics on which FDA is also seeking public comment:
Public health concerns associated with use of HCs and
interacting drugs that might affect efficacy and safety.
PK and PD considerations in designing drug interaction
studies with HCs during drug development. Key elements in designing a
study include a mechanistic understanding of potential DDI mechanisms,
the choice of contraceptive products and their dose, study population/
duration, and proper selection of a PK alone or PK-PD-based drug
interaction study approach.
Drug interaction study result interpretation and its
potential impact on guidance of HC use in women of childbearing
potential who are enrolled in clinical trials for other therapeutic
agents during drug development.
The current approach of translating the results from drug
interaction studies into labeling recommendations and opportunities to
improve the communication to healthcare providers.
Research opportunities and tools for investigating the
safe use of HCs in the presence of other drugs.
The input received may be used to refine FDA's thinking on the drug
interaction study design with HCs and labeling communication of drug
interaction risks with HCs.
III. Meeting Attendance and Participation
If you wish to attend these meetings, register online at https://www.surveymonkey.com/r/HC-DDIMeeting. Please register by October 9,
2015. Those who are unable to attend the meetings in person can
register to view a live Web cast of the meetings. You will be asked to
indicate in your registration whether you plan to attend in person or
via the Web cast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meetings will be based on space availability. If you need
special accommodations because of disability, please contact Christine
Le (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
meeting.
FDA will hold an open public comment period during the November 9,
2015, public meeting to give the public an opportunity to comment.
Registration for open public comment will occur at the registration
desk on the day of the meeting on a first-come, first-served basis.
IV. Comments
Regardless of whether you attend this meeting, you can submit
electronic or written comments, including responses to the public
docket (see ADDRESS above), by December 15, 2015. 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.
V. Transcripts
Transcripts for the November 9, 2015, meeting will be posted, when
available, at https://www.fda.gov/Drugs/NewsEvents/ucm459342.htm.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22949 Filed 9-10-15; 8:45 am]
BILLING CODE 4164-01-P
