82 FR 45597 - Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 188 (September 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45597-45600 | |
| FR Document | 2017-20905 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Pages 45597-45600] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20905] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5608] Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA's newly established Opioid Policy Steering Committee (OPSC). Opioid addiction and the resulting overdoses and deaths have created a national crisis, which requires action by federal agencies that may in some instances be unprecedented in order to address the situation and attempt to turn the tide on the crisis. As a public health agency [[Page 45598]] responding to the crisis, FDA seek public input as it considers how its authorities can or should be used to address this crisis. This information will help the Agency understand areas of focus important to the public and identify and address opioid product and policy issues that need clarification. FDA is especially interested in hearing from interested parties in three key areas: What more can FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented? DATES: Submit either electronic or written comments by December 28, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 28, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 28, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-5608 for ``Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kathleen Davies, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205. SUPPLEMENTARY INFORMATION: On April 19, 2017, the Secretary of Health and Human Services announced the HHS strategy for fighting the opioid crisis. The five point strategy includes: (1) Improving access to prevention, treatment, and recovery services; (2) targeting availability and distribution of overdose-reversing drugs; (3) strengthening timely public health data and reporting; (4) supporting cutting-edge research; and (5) advancing the practice of pain management. Following that announcement, on May 23, 2017, the Commissioner of Food and Drugs announced his intention to take more forceful steps to combat the opioid crisis. An OPSC was established to explore and develop additional tools or strategies FDA can use to confront this crisis. The OPSC has a broad mandate to consider steps that FDA can take to confront the opioid crisis. FDA is seeking suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, with regard to a number of topics related to three overarching questions: (1) What more can or should FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid- related regulatory decisions; (2) what steps can or should FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and (3) should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented? [[Page 45599]] I. Assessing Benefit and Risk in the Opioids Setting In a July 6, 2017, article in the Journal of the American Medical Association, FDA explained its approach to assessing the benefits and risks of drug products, describing a structured approach that, in the case of opioids, includes extensive additional review of the risks related to the potential misuse and abuse of these products. FDA explained that it is working to incorporate the effects of decisions on public health into its benefit-risk framework in a more quantitative manner that can supplement and enhance the strong qualitative work that the Agency already performs (Ref. 1). In addition, in March 2016, FDA commissioned a study from the National Academies of Sciences, Engineering, and Medicine to outline the state of the science regarding prescription opioid abuse and misuse, the evolving role that opioid analgesics play in pain management, and additional actions FDA should consider to address the opioid crisis with particular emphasis on strengthening its benefit-risk framework for opioids. That report was issued in July (Ref. 2). While FDA considers the report recommendations, we would like to solicit additional feedback that will supplement those recommendations. Specific questions on which FDA seeks comment relating to this topic are as follows: 1. How should FDA tailor, or otherwise amend, its assessment of benefit and risk in the context of opioid drugs to ensure that the Agency is giving adequate consideration to the risks associated with the labeled indication of these drugs and the risks associated with the potential abuse and misuse of these products? 2. Are there specific public health considerations other than misuse and abuse that FDA should incorporate into its current framework for benefit and risk assessment as a way to reduce the opioid addiction epidemic? That framework includes, but is not limited to, how FDA makes regulatory decisions to approve new opioids, evaluates their use in the postmarket setting, or limits or influences their prescribing through product labeling or other risk management measures. II. Steps To Promote Proper Prescribing and Dispensing Proper prescribing and dispensing are critical to successfully reducing opioid misuse and abuse. A 2016 Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain reported that, ``[w]hen opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.'' (Ref. 3.) And a recent analysis showed that, across six studies of patients who had undergone a variety of surgical procedures, 67 percent to 92 percent of patients reported unused opioid analgesics. Moreover, ``[r]ates of safe storage and/or disposal of unused opioids were low,'' resulting in an ``important reservoir of unused opioids available for nonmedical use . . . .'' (Ref. 4). There are clinical situations that may require a supply of opioid analgesics that exceeds current CDC guidelines and FDA wants to make sure that patients have what they need in those cases. But FDA believes there are situations in which patients are prescribed an opioid analgesic when a non-opioid pain treatment would be adequate or, when an opioid product is necessary, treatment with a shorter course of therapy would be more appropriate, and without specific requirements, variance in prescribing habits are likely to persist. Specific questions on which FDA seeks comment relating to this topic are as follows: 1. Should FDA consider adding a recommended duration of treatment for specific types of patient needs (e.g., for specific types of surgical procedures) to opioid analgesic product labeling? Or, should FDA work with prescriber groups that could, in turn, develop expert guidelines on proper prescribing by indication? 2. If opioid product labeling contained recommended duration of treatment for certain common types of patient needs, how should this information be used by FDA, other state and Federal health agencies, providers, and other intermediaries, such as health plans and pharmacy benefit managers, as the basis for making sure that opioid drug dispensing more appropriately and consistently aligns with the type of patient need for which a prescription is being written? 3. Are there steps FDA should take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice? 4. Are there other steps that FDA should take to help promote the prescribing of treatment durations that are appropriately tailored to a clinical patient need? III. Requirements for Prescriber Education Recently, the option of mandating education or training for health care professionals who prescribe opioid medications has been more widely discussed,\1\ and some states already are, or are considering, mandating such prescriber education. For example, as of July 1, 2017, health care professionals in New York State who are licensed to prescribe controlled substances must complete, and register their completion of, at least 3 hours of course work or training in pain management, palliative care, and addiction (Ref. 5). --------------------------------------------------------------------------- \1\ FDA acknowledges the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting, held May 3-4, 2016, discussed mandatory education for health care professionals (Docket No. FDA-2016-N-0820). --------------------------------------------------------------------------- Specific questions on which FDA seeks comment relating to this topic are as follows: 1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals to ensure that prescribing professionals are informed about appropriate prescribing and pain management recommendations, understand how to identify the risk of abuse in individual patients, know how to get patients with a substance use disorder into treatment, and know how to prescribe treatment for--and properly manage--patients with substance use disorders, among other educational goals? Are there other steps FDA could take to educate health care professionals to ensure that prescribing professionals are informed about appropriate prescribing and pain management recommendations? 2. How might FDA operationalize such a requirement if it were to pursue this policy goal? For example, should mandatory education apply to all prescribing health care professionals, or only a subset of prescribing health care professionals? If only a subset, how would FDA construct a framework that focuses mandatory education on only that subset--for example, by requiring mandatory education only for those writing prescriptions for longer durations as opposed to those for very short-term use? 3. What steps should FDA take to make implementing such mandatory education efficient and more feasible? For example, should FDA work collaboratively with state public health agencies, state licensing boards, provider organizations, such as medical specialty societies and health plans, or with other stakeholders, such as [[Page 45600]] pharmacy benefit managers, to integrate or avoid duplicating their educational programs or requirements? What other steps might FDA consider to make implementation less burdensome and more effective? IV. Additional Matters for Consideration 1. What other steps should FDA take to operationalize the above described goals? 2. Are there additional policy steps FDA should consider relating to the OPSC that are not identified in this notice? We invite interested parties to review these questions and submit comments to the docket for the OPSC to consider. In addition, we invite interested parties to submit additional policy considerations or recommendations for actions that FDA could or should undertake to help the Agency better address the opioid addiction crisis. V. References 1. Gottlieb, Scott and J. Woodcock. ``Marshaling FDA Benefit- Risk Expertise to Address the Current Opioid Abuse Epidemic.'' Journal of the American Medical Association. 2017;318(5):421-422. Doi:10.1001/jama.2017.9205. Available at http://jamanetwork.com/journals/jama/fullarticle/2643333. Accessed August 2017. 2. National Academies of Sciences, Engineering, and Medicine. ``Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use (2017), Consensus Study Report.'' Richard J. Bonnie, Morgan A. Ford, and Jonathan K. Phillips (eds.). Available at https://www.nap.edu/catalog/24781/pain-management-and-the-opioid-epidemic-balancing-societal-and-individual. Accessed August 2017. 3. Dowell, D., T. M. Haegerich, and R. Chou. ``CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016.'' Item 6 in ``Determining When to Initiate or Continue Opioids for Chronic Pain.'' Morbidity and Mortality Weekly Report Recommendations and Reports 2016;65(No. RR-1):1-49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1. Accessed August 2017. 4. Bicket, M. C., J. J. Long, P. J. Pronovost, et al. ``Prescription Opioid Analgesics Commonly Unused After Surgery, A Systematic Review.'' JAMA Surgery. Published online August 2, 2017. DOI:10.1001/jamasurg.2017.0831. Available at http://jamanetwork.com/journals/jamasurgery/fullarticle/2644905. Accessed August 2017. 5. New York State Department of Health, Mandatory Prescriber Education. Available at https://www.health.ny.gov/professionals/narcotic/mandatory_prescriber_education/. Accessed August 2017. Dated: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20905 Filed 9-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45597
Advisory Committee; Notice of Meeting; 1–800–741–8138 (301–443–0572 in the public hearing session. The contact
Establishment of a Public Docket; Washington, DC area). A notice in the person will notify interested persons
Request for Comments.’’ Received Federal Register about last minute regarding their request to speak by
comments, those filed in a timely modifications that impact a previously October 25, 2017.
manner (see ADDRESSES), will be placed announced advisory committee meeting Persons attending FDA’s advisory
in the docket and, except for those cannot always be published quickly committee meetings are advised that
submitted as ‘‘Confidential enough to provide timely notice. FDA is not responsible for providing
Submissions,’’ publicly viewable at Therefore, you should always check access to electrical outlets.
https://www.regulations.gov or at the FDA’s Web site at https://www.fda.gov/ FDA welcomes the attendance of the
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and public at its advisory committee
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory meetings and will make every effort to
Friday. committee meeting link, or call the accommodate persons with disabilities.
• Confidential Submissions—To advisory committee information line to If you require special accommodations
submit a comment with confidential learn about possible modifications due to a disability, please contact
information that you do not wish to be before coming to the meeting. Lauren D. Tesh at least 7 days in
made publicly available, submit your SUPPLEMENTARY INFORMATION:
advance of the meeting.
comments only as a written/paper FDA is committed to the orderly
Agenda: The committee will discuss
submission. You should submit two conduct of its advisory committee
new drug application (NDA) 209367,
copies total. One copy will include the meetings. Please visit our Web site at
ciprofloxacin inhalation powder,
information you claim to be confidential https://www.fda.gov/
sponsored by Bayer HealthCare
with a heading or cover note that states AdvisoryCommittees/
Pharmaceuticals, Inc., for the proposed
‘‘THIS DOCUMENT CONTAINS AboutAdvisoryCommittees/
indication of reduction of exacerbations
CONFIDENTIAL INFORMATION.’’ FDA ucm111462.htm for procedures on
in non-cystic fibrosis bronchiectasis
will review this copy, including the public conduct during advisory
(NCFB) adult patients (≥18 years of age)
claimed confidential information, in its committee meetings.
with respiratory bacterial pathogens. Notice of this meeting is given under
consideration of comments. The second FDA intends to make background
copy, which will have the claimed the Federal Advisory Committee Act (5
material available to the public no later U.S.C. app. 2).
confidential information redacted/ than 2 business days before the meeting.
blacked out, will be available for public If FDA is unable to post the background Dated: September 26, 2017.
viewing and posted on https:// material on its Web site prior to the Anna K. Abram,
www.regulations.gov. Submit both meeting, the background material will Deputy Commissioner for Policy, Planning,
copies to the Dockets Management Staff. be made publicly available at the Legislation, and Analysis.
If you do not wish your name and location of the advisory committee [FR Doc. 2017–20949 Filed 9–28–17; 8:45 am]
contact information to be made publicly meeting, and the background material BILLING CODE 4164–01–P
available, you can provide this will be posted on FDA’s Web site after
information on the cover sheet and not the meeting. Background material is
in the body of your comments and you available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
must identify the information as AdvisoryCommittees/Calendar/ HUMAN SERVICES
‘‘confidential.’’ Any information marked default.htm. Scroll down to the
as ‘‘confidential’’ will not be disclosed Food and Drug Administration
appropriate advisory committee meeting
except in accordance with 21 CFR 10.20 link. [Docket No. FDA–2017–N–5608]
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, Opioid Policy Steering Committee;
of comments to public dockets, see 80 orally or in writing, on issues pending Establishment of a Public Docket;
FR 56469, September 18, 2015, or access before the committee. All electronic and Request for Comments
the information at: https://www.gpo.gov/ written submissions submitted to the AGENCY: Food and Drug Administration,
fdsys/pkg/FR-2015-09-18/pdf/2015- Docket (see ADDRESSES) on or before HHS.
23389.pdf. November 1, 2017, will be provided to
Docket: For access to the docket to ACTION: Notice; request for comments.
the committee. Oral presentations from
read background documents or the the public will be scheduled between SUMMARY: The Food and Drug
electronic and written/paper comments approximately 1:30 p.m. and 2:30 p.m. Administration (FDA or Agency) is
received, go to https:// Those individuals interested in making establishing a public docket to solicit
www.regulations.gov and insert the formal oral presentations should notify suggestions, recommendations, and
docket number, found in brackets in the the contact person and submit a brief comments from interested parties,
heading of this document, into the statement of the general nature of the including patients and patient
‘‘Search’’ box and follow the prompts evidence or arguments they wish to representatives, health care
and/or go to the Dockets Management present, the names and addresses of professionals, academic institutions,
Staff, 5630 Fishers Lane, Rm. 1061, proposed participants, and an regulated industry, and other interested
Rockville, MD 20852. indication of the approximate time organizations, on questions relevant to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: requested to make their presentation on FDA’s newly established Opioid Policy
Lauren D. Tesh, Center for Drug or before October 24, 2017. Time Steering Committee (OPSC). Opioid
Evaluation and Research, Food and allotted for each presentation may be addiction and the resulting overdoses
Drug Administration, 10903 New limited. If the number of registrants and deaths have created a national
Hampshire Ave., Bldg. 31, Rm. 2417, requesting to speak is greater than can crisis, which requires action by federal
Silver Spring, MD 20993–0002, 301– be reasonably accommodated during the agencies that may in some instances be
796–9001, Fax: 301–847–8533, email: scheduled open public hearing session, unprecedented in order to address the
AMDAC@fda.hhs.gov, or the FDA FDA may conduct a lottery to determine situation and attempt to turn the tide on
Advisory Committee Information Line, the speakers for the scheduled open the crisis. As a public health agency
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45785/page/1.svg)
![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45599
I. Assessing Benefit and Risk in the opioids are used for acute pain, III. Requirements for Prescriber
Opioids Setting clinicians should prescribe the lowest Education
In a July 6, 2017, article in the Journal effective dose of immediate-release Recently, the option of mandating
of the American Medical Association, opioids and should prescribe no greater education or training for health care
FDA explained its approach to assessing quantity than needed for the expected professionals who prescribe opioid
the benefits and risks of drug products, duration of pain severe enough to medications has been more widely
describing a structured approach that, in require opioids. Three days or less will discussed,1 and some states already are,
often be sufficient; more than seven or are considering, mandating such
the case of opioids, includes extensive
days will rarely be needed.’’ (Ref. 3.)
additional review of the risks related to prescriber education. For example, as of
And a recent analysis showed that,
the potential misuse and abuse of these July 1, 2017, health care professionals in
across six studies of patients who had
products. FDA explained that it is New York State who are licensed to
undergone a variety of surgical
working to incorporate the effects of prescribe controlled substances must
procedures, 67 percent to 92 percent of
decisions on public health into its complete, and register their completion
patients reported unused opioid
benefit-risk framework in a more of, at least 3 hours of course work or
analgesics. Moreover, ‘‘[r]ates of safe
quantitative manner that can training in pain management, palliative
storage and/or disposal of unused
supplement and enhance the strong care, and addiction (Ref. 5).
opioids were low,’’ resulting in an
qualitative work that the Agency already Specific questions on which FDA
‘‘important reservoir of unused opioids
performs (Ref. 1). In addition, in March seeks comment relating to this topic are
available for nonmedical use . . . .’’
2016, FDA commissioned a study from as follows:
(Ref. 4). There are clinical situations
the National Academies of Sciences, 1. Are there circumstances under
that may require a supply of opioid
Engineering, and Medicine to outline which FDA should require some form of
analgesics that exceeds current CDC
the state of the science regarding mandatory education for health care
guidelines and FDA wants to make sure
prescription opioid abuse and misuse, professionals to ensure that prescribing
that patients have what they need in
the evolving role that opioid analgesics those cases. But FDA believes there are professionals are informed about
play in pain management, and situations in which patients are appropriate prescribing and pain
additional actions FDA should consider prescribed an opioid analgesic when a management recommendations,
to address the opioid crisis with non-opioid pain treatment would be understand how to identify the risk of
particular emphasis on strengthening its adequate or, when an opioid product is abuse in individual patients, know how
benefit-risk framework for opioids. That necessary, treatment with a shorter to get patients with a substance use
report was issued in July (Ref. 2). While course of therapy would be more disorder into treatment, and know how
FDA considers the report appropriate, and without specific to prescribe treatment for—and properly
recommendations, we would like to requirements, variance in prescribing manage—patients with substance use
solicit additional feedback that will habits are likely to persist. disorders, among other educational
supplement those recommendations. Specific questions on which FDA goals? Are there other steps FDA could
Specific questions on which FDA seeks comment relating to this topic are take to educate health care professionals
seeks comment relating to this topic are as follows: to ensure that prescribing professionals
as follows: 1. Should FDA consider adding a are informed about appropriate
1. How should FDA tailor, or recommended duration of treatment for prescribing and pain management
otherwise amend, its assessment of specific types of patient needs (e.g., for recommendations?
benefit and risk in the context of opioid specific types of surgical procedures) to 2. How might FDA operationalize
drugs to ensure that the Agency is opioid analgesic product labeling? Or, such a requirement if it were to pursue
giving adequate consideration to the should FDA work with prescriber this policy goal? For example, should
risks associated with the labeled groups that could, in turn, develop mandatory education apply to all
indication of these drugs and the risks expert guidelines on proper prescribing prescribing health care professionals, or
associated with the potential abuse and by indication? only a subset of prescribing health care
misuse of these products? 2. If opioid product labeling professionals? If only a subset, how
2. Are there specific public health contained recommended duration of would FDA construct a framework that
considerations other than misuse and treatment for certain common types of focuses mandatory education on only
abuse that FDA should incorporate into patient needs, how should this that subset—for example, by requiring
its current framework for benefit and information be used by FDA, other state mandatory education only for those
risk assessment as a way to reduce the and Federal health agencies, providers, writing prescriptions for longer
opioid addiction epidemic? That and other intermediaries, such as health durations as opposed to those for very
framework includes, but is not limited plans and pharmacy benefit managers, short-term use?
to, how FDA makes regulatory decisions as the basis for making sure that opioid 3. What steps should FDA take to
to approve new opioids, evaluates their drug dispensing more appropriately and make implementing such mandatory
use in the postmarket setting, or limits consistently aligns with the type of education efficient and more feasible?
or influences their prescribing through patient need for which a prescription is For example, should FDA work
product labeling or other risk being written? collaboratively with state public health
management measures. 3. Are there steps FDA should take agencies, state licensing boards,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
with respect to dispensing and provider organizations, such as medical
II. Steps To Promote Proper Prescribing specialty societies and health plans, or
packaging (e.g., unit of use) to facilitate
and Dispensing with other stakeholders, such as
consistency of and promote appropriate
Proper prescribing and dispensing are prescribing practice?
critical to successfully reducing opioid 4. Are there other steps that FDA 1 FDA acknowledges the Joint Meeting of the Drug
misuse and abuse. A 2016 Centers for should take to help promote the Safety and Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug Products
Disease Control and Prevention (CDC) prescribing of treatment durations that Advisory Committee Meeting, held May 3–4, 2016,
Guideline for Prescribing Opioids for are appropriately tailored to a clinical discussed mandatory education for health care
Chronic Pain reported that, ‘‘[w]hen patient need? professionals (Docket No. FDA–2016–N–0820).
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45785/page/3.svg)
![45600 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
pharmacy benefit managers, to integrate jamasurgery/fullarticle/2644905. Accessed of the information to be collected; and
or avoid duplicating their educational August 2017. (4) the use of automated collection
programs or requirements? What other 5. New York State Department of Health, techniques or other forms of information
steps might FDA consider to make Mandatory Prescriber Education. Available at technology to minimize the information
https://www.health.ny.gov/professionals/
implementation less burdensome and narcotic/mandatory_prescriber_education/.
collection burden.
more effective? Accessed August 2017. Information Collection Request Title:
Prevention Communication Formative
IV. Additional Matters for Dated: September 26, 2017.
Research—Revision—OMB No. 0990–
Consideration Anna K. Abram, 0281.
1. What other steps should FDA take Deputy Commissioner for Policy, Planning, Abstract: The Office of Disease
to operationalize the above described Legislation, and Analysis. Prevention and Health Promotion
goals? [FR Doc. 2017–20905 Filed 9–28–17; 8:45 am] (ODPHP) is focused on developing and
2. Are there additional policy steps BILLING CODE 4164–01–P disseminating health information to the
FDA should consider relating to the public. ODPHP faces an increasingly
OPSC that are not identified in this urgent interest in finding effective ways
notice? DEPARTMENT OF HEALTH AND to communicate health information to
We invite interested parties to review HUMAN SERVICES America’s diverse population. ODPHP
these questions and submit comments to strives to be responsive to the needs of
the docket for the OPSC to consider. In Office of the Secretary
America’s diverse audiences while
addition, we invite interested parties to [HHS–OS–0990–0281–60D] simultaneously serving all Americans
submit additional policy considerations across a range of channels, from print to
or recommendations for actions that Agency Generic Information Collection new communication technologies. To
FDA could or should undertake to help Activities; Proposed Collection; Public carry out prevention information efforts,
the Agency better address the opioid Comment Request ODPHP is committed to conducting
addiction crisis. formative and usability research to
AGENCY: Office of the Secretary, HHS.
V. References ACTION: Notice. provide guidance on the development
and implementation of their
1. Gottlieb, Scott and J. Woodcock.
SUMMARY: In compliance with the communication and education efforts.
‘‘Marshaling FDA Benefit-Risk Expertise to
Address the Current Opioid Abuse requirement of the Paperwork The information collected will be used
Epidemic.’’ Journal of the American Medical Reduction Act of 1995, the Office of the to improve communication, products,
Association. 2017;318(5):421–422. Secretary (OS), Department of Health and services that support key office
Doi:10.1001/jama.2017.9205. Available at and Human Services, is publishing the activities including: Healthy People,
http://jamanetwork.com/journals/jama/ following summary of a proposed Dietary Guidelines for Americans,
fullarticle/2643333. Accessed August 2017. collection for public comment. Physical Activity Guidelines for
2. National Academies of Sciences, Americans, healthfinder.gov, and
DATES: Comments on the ICR must be
Engineering, and Medicine. ‘‘Pain increasing health care quality and
Management and the Opioid Epidemic: received on or before November 28,
2017. patient safety. ODPHP communicates
Balancing Societal and Individual Benefits
and Risks of Prescription Opioid Use (2017), through its Web sites
ADDRESSES: Submit your comments to (www.healthfinder.gov,
Consensus Study Report.’’ Richard J. Bonnie, Sherrette.Funn@hhs.gov or by calling
Morgan A. Ford, and Jonathan K. Phillips www.HealthyPeople.gov,
(202) 795–7714. www.health.gov) and through other
(eds.). Available at https://www.nap.edu/
catalog/24781/pain-management-and-the- FOR FURTHER INFORMATION CONTACT: channels including social media, print
opioid-epidemic-balancing-societal-and- When submitting comments or materials, interactive training modules,
individual. Accessed August 2017. requesting information, please include and reports. Data collection will be
3. Dowell, D., T. M. Haegerich, and R. the document identifier 0990–0281–60D qualitative and quantitative and may
Chou. ‘‘CDC Guideline for Prescribing and project title for reference, to the include in-depth interviews, focus
Opioids for Chronic Pain—United States, Report Clearance Officer, Sherrette
2016.’’ Item 6 in ‘‘Determining When to groups, web-based surveys, omnibus
Funn. surveys, card sorting, and various forms
Initiate or Continue Opioids for Chronic
Pain.’’ Morbidity and Mortality Weekly SUPPLEMENTARY INFORMATION: Interested of usability testing of materials and
Report Recommendations and Reports persons are invited to send comments interactive tools to assess the public’s
2016;65(No. RR–1):1–49. DOI: http:// regarding this burden estimate or any understanding of disease prevention
dx.doi.org/10.15585/mmwr.rr6501e1. other aspect of this collection of and health promotion content,
Accessed August 2017. information, including any of the responses to prototype materials, and
4. Bicket, M. C., J. J. Long, P. J. Pronovost, following subjects: (1) The necessity and barriers to effective use.
et al. ‘‘Prescription Opioid Analgesics
Commonly Unused After Surgery, A
utility of the proposed information The program is requesting a 3-year
Systematic Review.’’ JAMA Surgery. collection for the proper performance of clearance.
Published online August 2, 2017. the agency’s functions; (2) the accuracy Likely Respondents: Respondents are
DOI:10.1001/jamasurg.2017.0831. Available of the estimated burden; (3) ways to likely to be either consumers or health
at http://jamanetwork.com/journals/ enhance the quality, utility, and clarity professionals.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number Average burden/ Total response
Number of
Data collection task Instrument/form name responses/ response burden
respondents respondent (in hours) (in hours)
In-depth interviews ............... Screener ............................... 1,500 1 10/60 250
Interview ............................... 500 1 1.00 500
Focus groups ........................ Screener ............................... 2,925 1 10/60 487.5
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45785/page/4.svg)
Document Created: 2017-09-29 03:26:48
Document Modified: 2017-09-29 03:26:48
| 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; request for comments. | |
| Dates | Submit either electronic or written comments by December 28, 2017. | |
| Contact | Kathleen Davies, Office of Medical Products and Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205. | |
| FR Citation | 82 FR 45597 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR