81 FR 14975 - Patient Engagement Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 54 (March 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 54 (March 21, 2016)
| Page Range | 14975-14976 | |
| FR Document | 2016-06240 |
[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)] [Rules and Regulations] [Pages 14975-14976] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06240] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No. FDA-2016-N-0001] Patient Engagement Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to add the Patient Engagement Advisory Committee. DATES: This rule is effective March 21, 2016. FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, email: [email protected], 301-796-8398. SUPPLEMENTARY INFORMATION: The Patient Engagement Advisory Committee (the Committee) was established on October 6, 2015 (80 FR 57007, September 21, 2015). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner), or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee will be composed of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities who are knowledgeable in areas such as clinical research, primary care patient experience, and healthcare needs of patient groups in the United States, or who are experienced in the work of patient and health professional organizations, methodologies for eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer- oriented organizations or other interested persons. The function of the Committee is to provide advice to the Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes, and device- related quality of life or health status issues are among the topics that may be considered by the Committee. The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. The Committee name and function were established with the Committee charter on October 6, 2015. Therefore, the Agency is amending 21 CFR 14.100 to add the Committee name and function to its current list as set forth in the regulatory text of this document. Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule is merely codifying the addition of the name and function of the Patient Engagement Advisory Committee to reflect the committee charter. Therefore, the Agency is amending 21 CFR 14.100 to add paragraph (d)(5) as set forth in the regulatory text of this document. [[Page 14976]] List of Subjects in 21 CFR Part 14 Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows: PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 0 1. The authority citation for 21 CFR part 14 continues to read as follows: Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41- 50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. L. 113-54. 0 2. In Sec. 14.100, add paragraph (d)(5) to read as follows: Sec. 14.100 List of standing advisory committees. * * * * * (d) * * * (5) Patient Engagement Advisory Committee. (i) Date Established: October 6, 2015. (ii) Function: Provides advice to the Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes, and device-related quality of life or health status issues are among the topics that may be considered by the Committee. The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. * * * * * Dated: March 15, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-06240 Filed 3-18-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 54 / Monday, March 21, 2016 / Rules and Regulations 14975
derivatives markets to hedge risk—and who, I fully recognize the difficulty in organizations, methodologies for
we should always remember, did not cause distinguishing between different types of eliciting patient preferences, and
the financial crisis. Trade options are a type physical contracts. If a particular contract or strategies for communicating benefits,
of commodity option primarily used in the an element of a contract serves an economic
agricultural, energy and manufacturing purpose similar to an option, I believe the
risks, and clinical outcomes to patients
sectors. Today, the Commission has finalized best course of action is to exercise caution and research subjects. Members will be
some amendments to its rules that recognize and not assume your contract is outside of invited to serve for overlapping terms of
trade options are different from the swaps our jurisdiction based on an interpretation. up to 4 years. Almost all non-Federal
that are the focus of the Dodd-Frank reforms. While it may seem fine for a person using members of this committee serve as
These changes will reduce the burdens on these contracts to hope that the interpretation Special Government Employees. The
these commercial businesses and allow them is not called into question, I believe it would
to better address commercial risk.
core of voting members may include one
be wise, as a backstop, to make sure it also technically qualified member, selected
The action we have taken today will falls within the trade option exemption.
eliminate any potential obligation of by the Commissioner or designee, who
commercial participants, who are not swap [FR Doc. 2016–06260 Filed 3–18–16; 8:45 am] is identified with consumer interests
dealers (SD) or major swap participants BILLING CODE 6351–01–P and is recommended by either a
(MSP), to report trade options to a swap data consortium of consumer-oriented
repository. We also have eliminated the
requirement that these entities must report
organizations or other interested
DEPARTMENT OF HEALTH AND persons.
their trade option activities on ‘‘Form TO,’’
and we have eliminated Form TO altogether.
HUMAN SERVICES
The function of the Committee is to
Further, we have ended the swap-related provide advice to the Commissioner on
recordkeeping requirements for these end- Food and Drug Administration
complex issues relating to medical
users in connection with their trade option
activities, although when transacting in trade 21 CFR Part 14 devices, the regulation of devices, and
options with SDs or MSPs, they will need to their use by patients. Agency guidance
[Docket No. FDA–2016–N–0001]
obtain a legal entity identifier. These changes and policies, clinical trial or registry
will reduce burdens and costs for trade design, patient preference study design,
option counterparties that are not SDs or
Patient Engagement Advisory
Committee benefit-risk determinations, device
MSPs and, in particular, for smaller end- labeling, unmet clinical needs, available
users. AGENCY: Food and Drug Administration,
We also have decided not to impose a alternatives, patient reported outcomes,
requirement in the proposed rule that a HHS. and device-related quality of life or
commercial participant would need to ACTION: Final rule. health status issues are among the topics
provide notice to the Commission of its trade that may be considered by the
options activities if such activities have a SUMMARY: The Food and Drug Committee. The Committee provides
value of more than $1 billion in any calendar Administration (FDA) is amending the relevant skills and perspectives in order
year. This followed careful consideration of standing advisory committees’
the benefits of such information to the
to improve communication of benefits,
regulations to add the Patient risks, and clinical outcomes, and
Commission, as compared with the Engagement Advisory Committee.
difficulties commercial end-users would face increase integration of patient
in valuating, tracking, and classifying their DATES: This rule is effective March 21, perspectives into the regulatory process
trade options. 2016. for medical devices. It performs its
I’m pleased that today we have addressed FOR FURTHER INFORMATION CONTACT: duties by identifying new approaches,
some reasonable concerns of commercial Letise Williams, Office of Center promoting innovation, recognizing
end-users who are the critical users of the Director, Center for Devices and
derivatives markets. This is just one of the unforeseen risks or barriers, and
many actions we have taken in this regard. Radiological Health, Food and Drug identifying unintended consequences
We will continue to evaluate our rules with Administration, 10903 New Hampshire that could result from FDA policy.
an eye towards the concerns of these Ave., Silver Spring, MD 20993, email: The Committee name and function
businesses. I thank my fellow Commissioners Letise.Williams@fda.hhs.gov, 301–796–
for supporting today’s action.
were established with the Committee
8398.
charter on October 6, 2015. Therefore,
Appendix 3—Concurring Statement of SUPPLEMENTARY INFORMATION: The the Agency is amending 21 CFR 14.100
Commissioner Sharon Y. Bowen Patient Engagement Advisory to add the Committee name and
Our ruling today provides additional Committee (the Committee) was function to its current list as set forth in
clarity for trade options, but I encourage established on October 6, 2015 (80 FR the regulatory text of this document.
market participants to look at it closely. 57007, September 21, 2015).
Under 5 U.S.C. 553(b)(3)(B) and (d)
Trade options have been caught in a The Committee will provide advice to
and 21 CFR 10.40(d) and (e), the Agency
difficult legal bind. Congress sought to the Commissioner of Food and Drugs
ensure that people could not evade our finds good cause to dispense with notice
(the Commissioner), or designee, on
swaps regulations. It did so by both having and public comment procedures and to
complex issues relating to medical
a very broad definition of a swap, while also proceed to an immediate effective date
devices, regulation of devices, and their
limiting this Commission’s authority to on this rule. Notice and public comment
exempt swaps by regulation. use by patients.
The Committee will be composed of and a delayed effective date are
Fortunately, however, Congress preserved unnecessary and are not in the public
the Commission’s authority to exempt trade a core of nine voting members including
options, which is the authority we are once the Chair. Members and the Chair are interest as this final rule is merely
again using today. Importantly, this selected by the Commissioner or codifying the addition of the name and
exemption provides additional legal certainty designee from among authorities who function of the Patient Engagement
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that our interpretations cannot. But we are knowledgeable in areas such as Advisory Committee to reflect the
cannot overrule the Commodity Exchange committee charter.
Act with regulations and interpretations; we
clinical research, primary care patient
will always be bound by that statute. experience, and healthcare needs of Therefore, the Agency is amending 21
Therefore, I want to caution anyone tempted patient groups in the United States, or CFR 14.100 to add paragraph (d)(5) as
to rely on an interpretation to avoid CFTC who are experienced in the work of set forth in the regulatory text of this
jurisdiction when it comes to options. patient and health professional document.
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![14976 Federal Register / Vol. 81, No. 54 / Monday, March 21, 2016 / Rules and Regulations
List of Subjects in 21 CFR Part 14 DEPARTMENT OF THE INTERIOR unchanged and this will be the final
extension of the effective date.
Administrative practice and Bureau of Indian Affairs The BIA has determined that the
procedure, Advisory committees, Color extension of the effective date and
additives, Drugs, Radiation protection. 25 CFR Part 169 compliance date without prior public
Therefore, under the Federal Food, notice and comment is in the public
[156A2100DD/AAKC001030/ interest because it would allow more
Drug, and Cosmetic Act and under A0A501010.999900 253G] time for the public to comply with the
authority delegated to the Commissioner
RIN 1076–AF20 rule. This is a rule of agency procedure
of Food and Drugs, 21 CFR part 14 is
or practice that is exempt from notice
amended as follows:
Rights-of-Way on Indian Land and comment rulemaking under 5
PART 14—PUBLIC HEARING BEFORE U.S.C. 553(b)(A).
AGENCY: Bureau of Indian Affairs,
A PUBLIC ADVISORY COMMITTEE Interior. Correction
ACTION: Final rule; extension of effective In FR Rule Doc. No. 2015–28548,
■ 1. The authority citation for 21 CFR date and compliance date. published November 19, 2015, at 80 FR
part 14 continues to read as follows: 72492, make the following corrections:
Authority: 5 U.S.C. App. 2; 15 U.S.C. SUMMARY: The Bureau of Indian Affairs
■ 1. On page 72537, in the center and
1451–1461; 21 U.S.C. 41–50, 141–149, 321– (BIA) is announcing the extension of the
right columns, in revised § 169.7,
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 effective date of the final rule published
remove the date ‘‘December 21, 2015’’
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; November 19, 2015 governing rights-of-
wherever it appears and add in its place
Pub. L. 108–155; Pub. L. 113–54. way on Indian land, which was
‘‘April 21, 2016’’.
scheduled to take effect on December
■ 2. In § 14.100, add paragraph (d)(5) to 21, 2015, and later extended to March ■ 2. On page 72537, in the right column,
read as follows: 21, 2016. The final rule will now take in paragraph (d) of revised § 169.7,
effect on April 21, 2016. The BIA is also remove the date ‘‘April 18, 2016’’ and
§ 14.100 List of standing advisory announcing an extension of the add in its place ‘‘August 16, 2016’’.
committees. compliance date by which Dated: March 15, 2016.
* * * * * documentation of past assignments Lawrence S. Roberts,
(d) * * * must be submitted from the extended Acting Assistant Secretary—Indian Affairs.
date of July 17, 2016, to August 16,
(5) Patient Engagement Advisory 2016. The final rule comprehensively
[FR Doc. 2016–06269 Filed 3–18–16; 8:45 am]
Committee. updates and streamlines the process for BILLING CODE 4337–15–P
(i) Date Established: October 6, 2015. obtaining Bureau of Indian Affairs (BIA)
(ii) Function: Provides advice to the grants of rights-of-way on Indian land
and BIA land, while supporting tribal DEPARTMENT OF HOMELAND
Commissioner on complex issues SECURITY
relating to medical devices, the self-determination and self-governance.
regulation of devices, and their use by DATES: The effective date of the final Coast Guard
patients. Agency guidance and policies, rule published on November 19, 2015
clinical trial or registry design, patient (80 FR 72492) is extended until April 33 CFR Part 117
preference study design, benefit-risk 21, 2016. The compliance date for
submission of documentation of past [Docket No. USCG–2016–0183]
determinations, device labeling, unmet
clinical needs, available alternatives, assignments is extended until August
Drawbridge Operation Regulation;
patient reported outcomes, and device- 16, 2016.
Trent River, New Bern, NC
related quality of life or health status FOR FURTHER INFORMATION CONTACT: Ms.
issues are among the topics that may be Elizabeth Appel, Director, Office of AGENCY: Coast Guard, DHS.
considered by the Committee. The Regulatory Affairs & Collaborative ACTION:Notice of deviation from
Committee provides relevant skills and Action, (202) 273–4680; drawbridge regulation.
perspectives in order to improve elizabeth.appel@bia.gov.
SUMMARY: The Coast Guard has issued a
communication of benefits, risks, and SUPPLEMENTARY INFORMATION: On
temporary deviation from the operating
clinical outcomes, and increase November 19, 2015, BIA published a
schedule that governs the US 70 (Alfred
integration of patient perspectives into final rule addressing rights-of-way on
C. Cunningham) Bridge across the Trent
the regulatory process for medical Indian land and BIA land. See 80 FR
River, mile 0.0, at New Bern, NC. The
devices. It performs its duties by 72492. In a document published
deviation is necessary to ensure the
December 21, 2015, BIA extended the
identifying new approaches, promoting safety of attendees to the annual
effective date of the rule to March 21,
innovation, recognizing unforeseen risks Mumfest celebration. This deviation
2016, in response to requests from tribes
or barriers, and identifying unintended allows the bridge draw span to remain
and industry in order to provide
consequences that could result from in the closed to navigation position at
additional time to prepare for
FDA policy. two hour increments to accommodate
implementation to ensure compliance.
* * * * * the free movement of pedestrians and
See 80 FR 79258. BIA is again extending
vehicles during the annual Mumfest
the effective date of the final rule. This
Lhorne on DSK5TPTVN1PROD with RULES
Dated: March 15, 2016. celebration.
Jill Hartzler Warner,
document extends the effective date of
the final rule to April 21, 2016, and DATES: This deviation is effective from
Associate Commissioner for Special Medical likewise extends the deadline for 9 a.m. on October 8, 2016 to 7 p.m. on
Programs. October 9, 2016.
providing BIA with documentation of
[FR Doc. 2016–06240 Filed 3–18–16; 8:45 am] past assignments to August 16, 2016. ADDRESSES: The docket for this
BILLING CODE 4164–01–P The substance of the rule remains deviation, [USCG–2016–0183] is
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Document Created: 2016-03-19 01:00:39
Document Modified: 2016-03-19 01:00:39
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective March 21, 2016. | |
| Contact | Letise Williams, Office of Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, email: [email protected], 301-796-8398. | |
| FR Citation | 81 FR 14975 | |
| CFR Associated | Administrative Practice and Procedure; Advisory Committees; Color Additives; Drugs and Radiation Protection |
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