81_FR_13846 81 FR 13796 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

81 FR 13796 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 50 (March 15, 2016)

Page Range13796-13797
FR Document2016-05748

Federal Register, Volume 81 Issue 50 (Tuesday, March 15, 2016) 
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13796-13797]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Anesthetic and Analgesic Drug Products Advisory Committee and the 
Drug Safety and Risk Management Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committees: Anesthetic and Analgesic Drug Products Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 5, 2016, from 8 a.m. 
to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Stephanie L. Begansky, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, email: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committees will be asked to discuss new drug 
application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, 
submitted by KemPharm, Inc., with the proposed indication of short-term 
(up to 14 days)

[[Page 13797]]

management of acute pain. The product has been formulated with the 
intent to provide abuse-deterrent properties. Benzhydrocodone is a 
hydrocodone prodrug which, according to the applicant, is rapidly 
converted into hydrocodone by enzymes in the gastrointestinal tract. 
The active drugs in this fixed-dose combination are hydrocodone and 
acetaminophen. The applicant has submitted data to support abuse-
deterrent properties for this product. The committees will be asked to 
discuss whether the applicant has demonstrated abuse-deterrent 
properties for their product that would support labeling, and whether 
the nasal route of abuse is relevant for combination products made up 
of hydrocodone and acetaminophen.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On May 5, 2016, from 9:15 a.m. to 5 p.m., the meeting is 
open to the public. Interested persons may present data, information, 
or views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
April 21, 2016. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before April 13, 2016. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by April 14, 2016.
    Closed Presentation of Data: On May 5, 2016, from 8 a.m. to 9:15 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). During this session, the committees will discuss the drug 
development program of an investigational abuse-deterrent opioid 
product.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Stephanie L. Begansky at least 7 days in advance of the 
meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05748 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P

13796 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices which are submitted via the Pet Event and the manufacturer or distributor/ reports will have the following data Tracking Network (PETNet); and (2) packer (if known)), the species affected, elements, many of which are drop down reports of animal food-related illness number of animals exposed to the menu choices: Product information and product defects associated with product, number of animals affected, (product name, lot code, guarantor animal food for livestock animals, body systems affected, product information, date and location of sample aquaculture species, and horses, which problem/defect, date of onset or the date collection, and product description); are submitted via LivestockNet. We are product problem was detected, the State laboratory information (sample revising the collection to include a third where the incident occurred, the origin identification number, the reason for type of report that would be submitted of the information, whether there are testing, whether the food was reported via ‘‘SampleNet.’’ SampleNet will supporting laboratory results, and to the Reportable Food Registry, who collect reports about animal food contact information for the reporting performed the analysis); and results laboratory samples considered member (i.e., name, telephone number information (analyte, test method, adulterated by State or FDA regulators. will be captured automatically when analytical results, whether the results SampleNet will allow Federal, State, member logs in to the system). For the contradict a label claim or guarantee, and Territorial regulatory and public LivestockNet report, additional data and whether action was taken as a result health agencies to share laboratory data elements specific to livestock animals of the sample analysis). related to adulterated samples for will be captured: Product details purposes of surveillance, mitigation, (indication of whether the product is a Description of Respondents: work planning, and supporting the medicated feed under 21 CFR Respondents to the collection of animal food standard requirements. 558.3(b)(8), product packaging, and information are Federal, State, and PETNet and LivestockNet reports intended purpose of the product), class Territorial regulatory and public health share the following common data of the animal species affected, and agency employees with membership elements, the majority of which are drop production loss. For PETNet reports, the access to the Animal Feed Network. down menu choices: Product details only additional data field is the animal FDA estimates the burden of this (product name, lot code, product form, life stage. The proposed SampleNet collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Average burden per Activity responses per Total hours respondents responses response respondent PETNet ................................. 20 5 100 0.25 (15 minutes) ................. 25 LivestockNet ......................... 20 5 100 0.25 (15 minutes) ................. 25 SampleNet ............................ 20 5 100 0.25 (15 minutes) ................. 25 Total ............................... .............................. .............................. .............................. ............................................... 75 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimate is based on our This notice announces a forthcoming and Research, Food and Drug experience with the tracking network meeting of a public advisory committee Administration, 10903 New Hampshire over the past 3 years. We estimate that of the Food and Drug Administration Ave., Bldg. 31, Rm. 2417, Silver Spring, we will receive an average of 5 (FDA). At least one portion of the MD 20993–0002, 301–796–9001, FAX: submissions from 20 respondents for meeting will be closed to the public. 301–847–8533, email: AADPAC@ each type of report, and that it will take Name of Committees: Anesthetic and fda.hhs.gov, or FDA Advisory 15 minutes (0.25 hour) per response. Analgesic Drug Products Advisory Committee Information Line, 1–800– Dated: March 9, 2016. Committee and the Drug Safety and Risk 741–8138 (301–443–0572 in the Management Advisory Committee. Washington, DC area). A notice in the Leslie Kux, General Function of the Committees: Federal Register about last minute Associate Commissioner for Policy. To provide advice and modifications that impact a previously [FR Doc. 2016–05757 Filed 3–14–16; 8:45 am] recommendations to the Agency on announced advisory committee meeting BILLING CODE 4164–01–P FDA’s regulatory issues. cannot always be published quickly Date and Time: The meeting will be enough to provide timely notice. held on May 5, 2016, from 8 a.m. to 5 Therefore, you should always check the DEPARTMENT OF HEALTH AND p.m. HUMAN SERVICES Agency’s Web site at http:// Location: FDA White Oak Campus, www.fda.gov/AdvisoryCommittees/ 10903 New Hampshire Ave., Bldg. 31 Food and Drug Administration default.htm and scroll down to the Conference Center, the Great Room (Rm. appropriate advisory committee meeting 1503), Silver Spring, MD 20993–0002. [Docket No. FDA–2016–N–0001] link, or call the advisory committee Answers to commonly asked questions information line to learn about possible including information regarding special asabaliauskas on DSK3SPTVN1PROD with NOTICES Anesthetic and Analgesic Drug modifications before coming to the accommodations due to a disability, Products Advisory Committee and the visitor parking, and transportation may meeting. Drug Safety and Risk Management be accessed at: http://www.fda.gov/ Agenda: The committees will be Advisory Committee; Notice of Meeting AdvisoryCommittees/ asked to discuss new drug application AGENCY: Food and Drug Administration, AboutAdvisoryCommittees/ (NDA) 208653, benzhydrocodone/ HHS. ucm408555.htm. acetaminophen oral tablets, submitted Contact Person: Stephanie L. by KemPharm, Inc., with the proposed ACTION: Notice. Begansky, Center for Drug Evaluation indication of short-term (up to 14 days) VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1

Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13797 management of acute pain. The product meeting will be closed to permit meet relevant legal and regulatory has been formulated with the intent to discussion and review of trade secret requirements. provide abuse-deterrent properties. and/or confidential commercial FOR FURTHER INFORMATION CONTACT: Benzhydrocodone is a hydrocodone information (5 U.S.C. 552b(c)(4)). prodrug which, according to the Stacy Kane, Center for Drug Evaluation During this session, the committees will applicant, is rapidly converted into and Research, Food and Drug discuss the drug development program hydrocodone by enzymes in the Administration, 10903 New Hampshire of an investigational abuse-deterrent gastrointestinal tract. The active drugs Ave., Bldg. 51, Rm. 6207, Silver Spring, opioid product. in this fixed-dose combination are MD 20993–0002, 301–796–8363, Persons attending FDA’s advisory hydrocodone and acetaminophen. The Stacy.Kane@fda.hhs.gov. committee meetings are advised that the applicant has submitted data to support Agency is not responsible for providing SUPPLEMENTARY INFORMATION: In 1984, abuse-deterrent properties for this access to electrical outlets. Congress enacted the Drug Price product. The committees will be asked FDA welcomes the attendance of the Competition and Patent Term to discuss whether the applicant has public at its advisory committee Restoration Act of 1984 (Pub. L. 98–417) demonstrated abuse-deterrent properties meetings and will make every effort to (the 1984 amendments), which for their product that would support accommodate persons with disabilities. authorized the approval of duplicate labeling, and whether the nasal route of If you require accommodations due to a versions of drug products approved abuse is relevant for combination disability, please contact Stephanie L. under an ANDA procedure. ANDA products made up of hydrocodone and Begansky at least 7 days in advance of applicants must, with certain acetaminophen. the meeting. exceptions, show that the drug for FDA intends to make background FDA is committed to the orderly which they are seeking approval material available to the public no later conduct of its advisory committee contains the same active ingredient in than 2 business days before the meeting. meetings. Please visit our Web site at the same strength and dosage form as If FDA is unable to post the background http://www.fda.gov/ the ‘‘listed drug,’’ which is a version of material on its Web site prior to the AdvisoryCommittees/ the drug that was previously approved. meeting, the background material will AboutAdvisoryCommittees/ ANDA applicants do not have to repeat be made publicly available at the ucm111462.htm for procedures on the extensive clinical testing otherwise location of the advisory committee public conduct during advisory necessary to gain approval of a new meeting, and the background material committee meetings. drug application (NDA). will be posted on FDA’s Web site after Notice of this meeting is given under The 1984 amendments include what the meeting. Background material is the Federal Advisory Committee Act (5 is now section 505(j)(7) of the Federal available at http://www.fda.gov/ U.S.C. app. 2). Food, Drug, and Cosmetic Act (21 U.S.C. AdvisoryCommittees/Calendar/ 355(j)(7)), which requires FDA to default.htm. Scroll down to the Dated: March 9, 2016. Jill Hartzler Warner, publish a list of all approved drugs. appropriate advisory committee meeting FDA publishes this list as part of the link. Associate Commissioner for Special Medical Programs. ‘‘Approved Drug Products With Procedure: On May 5, 2016, from 9:15 Therapeutic Equivalence Evaluations,’’ a.m. to 5 p.m., the meeting is open to [FR Doc. 2016–05748 Filed 3–14–16; 8:45 am] which is generally known as the the public. Interested persons may BILLING CODE 4164–01–P ‘‘Orange Book.’’ Under FDA regulations, present data, information, or views, a drug is removed from the list if the orally or in writing, on issues pending Agency withdraws or suspends before the committee. Written DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA submissions may be made to the contact HUMAN SERVICES person on or before April 21, 2016. Oral for reasons of safety or effectiveness, or presentations from the public will be Food and Drug Administration if FDA determines that the listed drug scheduled between approximately 1:30 was withdrawn from sale for reasons of p.m. and 2:30 p.m. Those individuals [Docket No. FDA–2016–N–0819] safety or effectiveness (21 CFR 314.162). interested in making formal oral Under § 314.161(a) (21 CFR Determination That KENALOG 314.161(a)), the Agency must determine presentations should notify the contact (Triamcinolone Acetonide) Lotion and person and submit a brief statement of whether a listed drug was withdrawn Other Drug Products Were Not from sale for reasons of safety or the general nature of the evidence or Withdrawn From Sale for Reasons of arguments they wish to present, the effectiveness: (1) Before an ANDA that Safety or Effectiveness refers to that listed drug may be names and addresses of proposed participants, and an indication of the AGENCY: Food and Drug Administration, approved, (2) whenever a listed drug is approximate time requested to make HHS. voluntarily withdrawn from sale and their presentation on or before April 13, ACTION: Notice. ANDAs that refer to the listed drug have 2016. Time allotted for each been approved, and (3) when a person presentation may be limited. If the SUMMARY: The Food and Drug petitions for such a determination under number of registrants requesting to Administration (FDA or Agency) has 21 CFR 10.25(a) and 10.30. Section speak is greater than can be reasonably determined that the drug products listed 314.161(d) provides that if FDA in this document were not withdrawn determines that a listed drug was asabaliauskas on DSK3SPTVN1PROD with NOTICES accommodated during the scheduled open public hearing session, FDA may from sale for reasons of safety or withdrawn from sale for safety or conduct a lottery to determine the effectiveness. This determination means effectiveness reasons, the Agency will speakers for the scheduled open public that FDA will not begin procedures to initiate proceedings that could result in hearing session. The contact person will withdraw approval of abbreviated new the withdrawal of approval of the notify interested persons regarding their drug applications (ANDAs) that refer to ANDAs that refer to the listed drug. request to speak by April 14, 2016. these drug products, and it will allow FDA has become aware that the drug Closed Presentation of Data: On May FDA to continue to approve ANDAs that products listed in the table in this 5, 2016, from 8 a.m. to 9:15 a.m., the refer to the products as long as they document are no longer being marketed. VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1


Document Created: 2016-03-15 04:07:04
Document Modified: 2016-03-15 04:07:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation81 FR 13796 
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