80 FR 54794 - Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications; Public Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 176 (September 11, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 176 (September 11, 2015)
| Page Range | 54794-54795 | |
| FR Document | 2015-22949 |
[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)] [Notices] [Pages 54794-54795] From the Federal Register Online [www.thefederalregister.org] [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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Submit electronic comments to http://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: http://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: [email protected]. 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 http://www.regulations.gov. V. Transcripts Transcripts for the November 9, 2015, meeting will be posted, when available, at http://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
![54794 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
other forms of information technology to or requirements that members of the Dated: September 8, 2015.
minimize the information collection public submit reports, keep records, or William N. Parham, III,
burden. provide information to a third party. Director, Paperwork Reduction Staff, Office
DATES: Comments must be received by Section 3506(c)(2)(A) of the PRA of Strategic Operations and Regulatory
requires federal agencies to publish a Affairs.
November 10, 2015.
60-day notice in the Federal Register [FR Doc. 2015–22944 Filed 9–10–15; 8:45 am]
ADDRESSES: When commenting, please
reference the document identifier or concerning each proposed collection of BILLING CODE 4120–01–P
OMB control number. To be assured information, including each proposed
consideration, comments and extension or reinstatement of an existing
DEPARTMENT OF HEALTH AND
recommendations must be submitted in collection of information, before
HUMAN SERVICES
any one of the following ways: submitting the collection to OMB for
1. Electronically. You may send your approval. To comply with this Food and Drug Administration
comments electronically to http:// requirement, CMS is publishing this
www.regulations.gov. Follow the [Docket No. FDA–2015–N–3156]
notice.
instructions for ‘‘Comment or Drug Interactions With Hormonal
Submission’’ or ‘‘More Search Options’’ Information Collection
Contraceptives: Public Health and
to find the information collection 1. Type of Information Collection Drug Development Implications; Public
document(s) that are accepting Meeting
Request: Revision of a currently
comments.
2. By regular mail. You may mail approved collection; AGENCY: Food and Drug Administration,
written comments to the following Title of Information Collection: HHS.
address: CMS, Office of Strategic Medicare Enrollment Application— ACTION: Notice of public meeting;
Operations and Regulatory Affairs, Durable Medical Equipment, request for comments.
Division of Regulations Development, Prosthetics, Orthotics and Supplies
Attention: Document Identifier/OMB (DMEPOS) Suppliers; Use: The primary SUMMARY: The Food and Drug
Control Number _________, Room C4– function of the CMS 855S Durable Administration (FDA) is announcing a
26–05, 7500 Security Boulevard, Medical Equipment, Prosthetics, public meeting entitled ‘‘Drug
Baltimore, Maryland 21244–1850. Interactions with Hormonal
Orthotics and Supplies (DMEPOS)
To obtain copies of a supporting Contraceptives: Public Health and Drug
supplier enrollment application is to Development Implications’’ and an
statement and any related forms for the gather information from a supplier that
proposed collection(s) summarized in opportunity for public comment on the
tells us who it is, whether it meets topic of drug interactions with
this notice, you may make your request certain qualifications to be a health care
using one of following: hormonal contraceptives (HCs). The
supplier, where it renders its services or goal of this public meeting is to provide
1. Access CMS’ Web site address at
http://www.cms.hhs.gov/ supplies, the identity of the owners of an opportunity for FDA to seek input
PaperworkReductionActof1995. the enrolling entity, and information from experts on the public health
2. Email your request, including your necessary to establish correct claims concerns associated with use of HCs and
address, phone number, OMB number, payment. interacting drugs that might affect
and CMS document identifier, to The goal of this revision of the CMS efficacy and safety, pharmacokinetic
Paperwork@cms.hhs.gov. 855S is to simplify and clarify the (PK)/pharmacodynamic (PD)
3. Call the Reports Clearance Office at current data collection and to remove considerations in designing drug
(410) 786–1326. obsolete and/or redundant questions. interaction studies with HCs during
FOR FURTHER INFORMATION CONTACT: Grammar and spelling errors were drug development, and approaches to
Reports Clearance Office at (410) 786– corrected. Limited informational text translating the results of drug
1326. interaction information into informative
has been added within the application
labeling and communication. The input
SUPPLEMENTARY INFORMATION: form and instructions in conjunction
received may be used to refine FDA’s
with links to Web sites when greater
Contents thinking on HC drug interaction study
detail is needed by the supplier. To design and interpretation, and labeling
This notice sets out a summary of the clarify current data collection
use and burden associated with the communication on drug interaction risk.
differentiations and to be in sync with
following information collections. More DATES: The public meeting will be held
accreditation coding, Section 3D on November 9, 2015, from 8:30 a.m. to
detailed information can be found in (‘‘Products and Services Furnished by
each collection’s supporting statement 4:30 p.m. Individuals who wish to
This Supplier’’) has been updated. This attend the meeting in person or via Web
and associated materials (see revision does not offer any new material
ADDRESSES). cast must register by October 9, 2015.
data collection. Form Number: CMS– Please submit either electronic or
CMS–855S Medicare Enrollment 855S (OMB Control Number: 0938– written comments by December 15,
Application—Durable Medical 1056); Frequency: Annually; Affected 2015, to receive consideration. See the
Equipment, Prosthetics, Orthotics and Public: Private Sector (Business or other SUPPLEMENTARY INFORMATION section for
Supplies (DMEPOS) Suppliers for-profits and Not-for-profit information on how to register for the
Under the PRA (44 U.S.C. 3501– institutions); Number of Respondents: meeting and submit electronic or
rmajette on DSK7SPTVN1PROD with NOTICES
3520), federal agencies must obtain 31,915; Total Annual Responses: written comments.
approval from the Office of Management 31,915; Total Annual Hours: 36,842. ADDRESSES: The meeting will be held at
and Budget (OMB) for each collection of (For policy questions regarding this the FDA White Oak Campus, 10903
information they conduct or sponsor. collection contact Kim McPhillips at New Hampshire Ave., Bldg. 31
The term ‘‘collection of information’’ is 410–786–5374.) Conference Center, Section A of the
defined in 44 U.S.C. 3502(3) and 5 CFR Great Room (Rm. 1503), Silver Spring,
1320.3(c) and includes agency requests MD 20993. Entrance for the public
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![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices 54795
meeting participants (non-FDA II. Discussion Topics for the Meeting FURTHER INFORMATION CONTACT) at least 7
employees) is through Building 1, where and for Public Comments days before the meeting.
routine security check procedures will FDA will hold an open public
The public meeting on November 9,
be performed. For more information on comment period during the November
2015, will include a discussion of the
parking and security procedures, please 9, 2015, public meeting to give the
following topics on which FDA is also
refer to http://www.fda.gov/AboutFDA/ public an opportunity to comment.
seeking public comment:
WorkingatFDA/BuildingsandFacilities/ • Public health concerns associated Registration for open public comment
WhiteOakCampusInformation/ with use of HCs and interacting drugs will occur at the registration desk on the
ucm241740.htm. that might affect efficacy and safety. day of the meeting on a first-come, first-
Submit electronic comments to • PK and PD considerations in served basis.
http://www.regulations.gov. Submit designing drug interaction studies with IV. Comments
written comments to the Division of HCs during drug development. Key
Dockets Management (HFA–305), Food Regardless of whether you attend this
elements in designing a study include a meeting, you can submit electronic or
and Drug Administration, 5630 Fishers mechanistic understanding of potential
Lane, Rm. 1061, Rockville, MD 20852. written comments, including responses
DDI mechanisms, the choice of to the public docket (see ADDRESS
All comments should be identified with contraceptive products and their dose,
the docket number found in brackets in above), by December 15, 2015. Received
study population/duration, and proper comments may be seen in the Division
the heading of this document. selection of a PK alone or PK–PD-based
FDA will post the agenda of Dockets Management between 9 a.m.
drug interaction study approach. and 4 p.m., Monday through Friday, and
approximately 5 days before the meeting • Drug interaction study result
at: http://www.fda.gov/Drugs/ will be posted to the docket at http://
interpretation and its potential impact www.regulations.gov.
NewsEvents/ucm459342.htm. on guidance of HC use in women of
FOR FURTHER INFORMATION CONTACT: childbearing potential who are enrolled V. Transcripts
Christine Le, Center for Drug Evaluation in clinical trials for other therapeutic Transcripts for the November 9, 2015,
and Research, Food and Drug agents during drug development. meeting will be posted, when available,
Administration, 10903 New Hampshire • The current approach of translating at http://www.fda.gov/Drugs/
Ave., Bldg. 51, Rm. 3196, Silver Spring, the results from drug interaction studies NewsEvents/ucm459342.htm.
MD 20993, 301–796–2398, email: into labeling recommendations and
Christine.Le@fda.hhs.gov. Dated: September 4, 2015.
opportunities to improve the
SUPPLEMENTARY INFORMATION: communication to healthcare providers. Leslie Kux,
• Research opportunities and tools for Associate Commissioner for Policy.
I. Background [FR Doc. 2015–22949 Filed 9–10–15; 8:45 am]
investigating the safe use of HCs in the
In general, HCs are highly effective in presence of other drugs. BILLING CODE 4164–01–P
preventing pregnancy when used The input received may be used to
correctly. However, concomitant use of refine FDA’s thinking on the drug
other drugs may affect the safety and/or interaction study design with HCs and DEPARTMENT OF HEALTH AND
efficacy of HCs due to drug interactions labeling communication of drug HUMAN SERVICES
affecting either blood levels (PK) and/or interaction risks with HCs.
physiologic effects (PD) of HC Meeting of the Presidential Advisory
components (e.g., estrogen and III. Meeting Attendance and Council on Combating Antibiotic-
progestins). Understanding drug Participation Resistant Bacteria
interaction potential of HCs and other If you wish to attend these meetings, AGENCY: Office of the Assistant
drugs is important when investigating register online at https:// Secretary for Health, Office of the
HC-related issues, and in the design and www.surveymonkey.com/r/HC- Secretary, Department of Health and
conduct of clinical trials. Evolving DDIMeeting. Please register by October Human Services.
knowledge on drug interaction 9, 2015. Those who are unable to attend ACTION: Notice.
mechanisms has led to new insights and the meetings in person can register to
increased interest in the clinical view a live Web cast of the meetings. SUMMARY: As stipulated by the Federal
investigation of drug interactions with You will be asked to indicate in your Advisory Committee Act, the
HCs. registration whether you plan to attend Department of Health and Human
Historically, most drug interaction in person or via the Web cast. Your Services (HHS) is hereby giving notice
studies conducted during drug registration should also contain your that a meeting of the Presidential
development with HCs have not had a complete contact information, including Advisory Council on Combating
clearly stated rationale for the choice of name, title, affiliation, address, email Antibiotic-Resistant Bacteria (the
HCs being studied. Questions remain as address, and phone number. Advisory Council) is scheduled for
to whether the study results of specific Seating will be limited, so early September 29, 2015, from 9:00 a.m. to
contraceptive steroids can be registration is recommended. 5:00 p.m. ET. The meeting will be open
extrapolated to other progestins or Registration is free and will be on a first- to the public; a public comment session
estrogens or other dose strengths. The come, first-served basis. However, FDA will be held during the meeting. Pre-
choice of HC is important because may limit the number of participants registration is required for members of
different progestins may have different from each organization based on space the public who wish to attend the
rmajette on DSK7SPTVN1PROD with NOTICES
metabolic and/or transporter pathways limitations. Registrants will receive meeting and who wish to participate in
and safety profiles. Without a confirmation once they have been the public comment session. Individuals
mechanistic understanding of the accepted. Onsite registration on the day who wish to attend the meeting and/or
underlying drug-drug interaction (DDI) of the meetings will be based on space send in their public comment via email
mechanism, it is difficult to interpret availability. If you need special should email CARB@hhs.gov.
and extrapolate study results from one accommodations because of disability, Registration information is available on
HC to another. please contact Christine Le (see FOR the Web site http://www.hhs.gov/ash/
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Document Created: 2015-12-15 10:00:04
Document Modified: 2015-12-15 10:00:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting; request for comments. | |
| 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. | |
| 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: [email protected] | |
| FR Citation | 80 FR 54794 |
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