83_FR_27121 83 FR 27009 - Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal

83 FR 27009 - Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 112 (June 11, 2018)

Page Range27009-27010
FR Document2018-12440

The Food and Drug Administration (FDA) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2020.

Federal Register, Volume 83 Issue 112 (Monday, June 11, 2018) 
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27009-27010]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1768]


Advisory Committee; Pharmacy Compounding Advisory Committee, 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Pharmacy Compounding Advisory Committee by the 
Commissioner of Food and Drugs (the Commissioner). The Commissioner has 
determined that it is in the public interest to renew the Pharmacy 
Compounding Advisory Committee for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until April 
25, 2020.

DATES: Authority for the Pharmacy Compounding Advisory Committee will 
expire on April 25, 2020, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Cindy Chee, 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, 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Pharmacy Compounding Advisory Committee (the Committee). 
The committee is a non-discretionary Federal advisory committee 
established to provide advice to the Commissioner.
    The Committee advises the Commissioner or designee in discharging 
responsibilities as they relate to compounding drugs for human use and, 
as required, any other product for which FDA has regulatory 
responsibility.
    The Committee shall provide advice on scientific, technical, and 
medical issues concerning drug compounding under sections 503A and 503B 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), 
and, as required, any other product for which FDA has regulatory 
responsibility, and make appropriate recommendations to the 
Commissioner.
    The Committee shall consist of a core of 12 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of

[[Page 27010]]

pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, 
medicine, and related specialties. These members will include 
representatives from the National Association of Boards of Pharmacy, 
the United States Pharmacopeia, pharmacists with current experience and 
expertise in compounding, physicians with background and knowledge in 
compounding, and patient and public health advocacy organizations. 
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 or more technically qualified members, selected by the Commissioner 
or designee, who are identified with consumer interests and are 
recommended by either a consortium of consumer-oriented organizations 
or other interested persons. In addition to the voting members, the 
Committee may include one or more non-voting members who are identified 
with industry interests.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm381305.htm or by contacting the Designated Federal Officer (see FOR 
FURTHER INFORMATION CONTACT). In light of the fact that no change has 
been made to the committee name or description of duties, no amendment 
will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12440 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices 27009 TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR section/activity burden per Total hours respondents per disclosures disclosure respondent 558.6(b)(3)–(b)(5) and (b)(7)–(b)(9); required dis- 3,050 246 750,000 0.125 (7 minutes) ...... 93,750 closures when a veterinarian issues a VFD. 558.6(c)(8); required disclosure (acknowledgement 1,000 5 5,000 0.125 (7 minutes) ...... 625 letter) from one distributor to another. Total .................................................................. ........................ ........................ ........................ .................................... 94,375 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The VFD regulation also contains indexed combination medicated feeds Commissioner). The Commissioner has several labeling provisions that are following this statement.) determined that it is in the public exempt from OMB review and approval (§ 558.6(b)(6)(ii)). interest to renew the Pharmacy under the PRA because they are a 3. ‘‘This VFD authorizes the use of the Compounding Advisory Committee for ‘‘public disclosure of information VFD drug(s) cited in this order in any an additional 2 years beyond the charter originally supplied by the Federal FDA-approved, conditionally approved, expiration date. The new charter will be government to the recipient for the or indexed combination(s) in medicated in effect until April 25, 2020. purpose of disclosure to the public’’ (5 feed that contains the VFD drug(s) as a DATES: Authority for the Pharmacy CFR 1320.3(c)(2)) and therefore do not component’’ (§ 558.6(b)(6)(iii)). Compounding Advisory Committee will constitute a ‘‘collection of information’’ These labeling statements are not expire on April 25, 2020, unless the under the PRA (44 U.S.C. 3501, et seq.). subject to review by OMB because, as Commissioner formally determines that All labeling and advertising for VFD stated previously, they are a ‘‘public renewal is in the public interest. drugs, combination VFD drugs, and disclosure of information originally FOR FURTHER INFORMATION CONTACT: feeds containing VFD drugs or supplied by the Federal government to Cindy Chee, Center for Drug Evaluation combination VFD drugs must the recipient for the purpose of and Research, Food and Drug prominently and conspicuously display disclosure to the public’’ (5 CFR Administration, 10903 New Hampshire the following cautionary statement: 1320.3(c)(2)) and therefore do not Ave., Bldg. 31, Rm. 2417, Silver Spring, ‘‘Caution: Federal law restricts constitute a ‘‘collection of information’’ MD 20993–0002, 301–796–9001, medicated feed containing this under the PRA (44 U.S.C. 3501, et seq.). The one-time burdens included in PCAC@fda.hhs.gov. veterinary feed directive (VFD) drug to use by or on the order of a licensed FDA’s analysis of the June 3, 2015, final SUPPLEMENTARY INFORMATION: Pursuant veterinarian’’ (§ 558.6(a)(6)). In addition, rule (80 FR 31708 at 31729 to 31732) are to 41 CFR 102–3.65 and approval by the the veterinarian must ensure that the not included in the estimate provided in Department of Health and Human following statement is included on the this notice. FDA’s estimate of the annual Services pursuant to 45 CFR part 11 and VFD (§ 558.6(b)(3)(xiii)): ‘‘Use of feed recurring burden for this information by the General Services Administration, containing this veterinary feed directive collection has not changed since the last FDA is announcing the renewal of the (VFD) drug in a manner other than as OMB approval. Pharmacy Compounding Advisory directed on the labeling (extralabel use) Committee (the Committee). The Dated: June 5, 2018. is not permitted.’’ committee is a non-discretionary Leslie Kux, The veterinarian may restrict VFD Federal advisory committee established Associate Commissioner for Policy. to provide advice to the Commissioner. authorization to only include the VFD [FR Doc. 2018–12448 Filed 6–8–18; 8:45 am] The Committee advises the drug(s) cited on the VFD or such authorization may be expanded to allow BILLING CODE 4164–01–P Commissioner or designee in the use of the cited VFD drug(s) along discharging responsibilities as they with one or more over-the-counter relate to compounding drugs for human animal drugs in an approved, DEPARTMENT OF HEALTH AND use and, as required, any other product conditionally approved, or indexed HUMAN SERVICES for which FDA has regulatory combination VFD drug (§ 558.6(b)(6)). responsibility. Food and Drug Administration The veterinarian must affirm his or her The Committee shall provide advice intent regarding combination VFD drugs [Docket No. FDA–2018–N–1768] on scientific, technical, and medical by including one of the following issues concerning drug compounding statements on the VFD: Advisory Committee; Pharmacy under sections 503A and 503B of the 1. ‘‘This VFD only authorizes the use Compounding Advisory Committee, Federal Food, Drug, and Cosmetic Act of the VFD drug(s) cited in this order Renewal (21 U.S.C. 353a and 353b), and, as and is not intended to authorize the use AGENCY: Food and Drug Administration, required, any other product for which of such drug(s) in combination with any HHS. FDA has regulatory responsibility, and other animal drugs’’ (§ 558.6(b)(6)(i)). ACTION:Notice; renewal of advisory make appropriate recommendations to daltland on DSKBBV9HB2PROD with NOTICES 2. ‘‘This VFD authorizes the use of the committee. the Commissioner. VFD drug(s) cited in this order in the The Committee shall consist of a core following FDA-approved, conditionally SUMMARY: The Food and Drug of 12 voting members including the approved, or indexed combination(s) in Administration (FDA) is announcing the Chair. Members and the Chair are medicated feed that contains the VFD renewal of the Pharmacy Compounding selected by the Commissioner or drug(s) as a component.’’ (List specific Advisory Committee by the designee from among authorities approved, conditionally approved, or Commissioner of Food and Drugs (the knowledgeable in the fields of VerDate Sep<11>2014 19:19 Jun 08, 2018 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\11JNN1.SGM 11JNN1

27010 Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices pharmaceutical compounding, ACTION:Notice; renewal of advisory voting members may include one pharmaceutical manufacturing, committee. technically qualified member, selected pharmacy, medicine, and related by the Commissioner or designee, who specialties. These members will include SUMMARY: The Food and Drug is identified with consumer interests representatives from the National Administration (FDA) is announcing the and is recommended by either a Association of Boards of Pharmacy, the renewal of the Peripheral and Central consortium of consumer-oriented United States Pharmacopeia, Nervous System Drugs Advisory organizations or other interested pharmacists with current experience Committee by the Commissioner of persons. In addition to the voting and expertise in compounding, Food and Drugs (the Commissioner). members, the Committee may include physicians with background and The Commissioner has determined that one non-voting member who is knowledge in compounding, and patient it is in the public interest to renew the identified with industry interests. and public health advocacy Peripheral and Central Nervous System Further information regarding the organizations. Members will be invited Drugs Advisory Committee for an most recent charter and other to serve for overlapping terms of up to additional 2 years beyond the charter information can be found at https:// 4 years. Almost all non-Federal expiration date. The new charter will be www.fda.gov/AdvisoryCommittees/ members of this Committee serve as in effect until June 4, 2020. CommitteesMeetingMaterials/Drugs/ Special Government Employees. The DATES: Authority for the Peripheral and PeripheralandCentralNervousSystem core of voting members may include one Central Nervous System Drugs Advisory DrugsAdvisoryCommittee/default.htm or more technically qualified members, Committee will expire on June 4, 2020, or by contacting the Designated Federal selected by the Commissioner or unless the Commissioner formally Officer (see FOR FURTHER INFORMATION designee, who are identified with determines that renewal is in the public CONTACT). In light of the fact that no consumer interests and are interest. change has been made to the committee recommended by either a consortium of FOR FURTHER INFORMATION CONTACT: name or description of duties, no consumer-oriented organizations or Yinghua Wang, Center for Drug amendment will be made to 21 CFR other interested persons. In addition to Evaluation and Research, Food and 14.100. the voting members, the Committee may This document is issued under the Drug Administration, 10903 New include one or more non-voting Federal Advisory Committee Act (5 Hampshire Ave., Bldg. 31, Rm. 2417, members who are identified with U.S.C. app.). For general information Silver Spring, MD 20993–0002; 301– industry interests. related to FDA advisory committees, 796–9001, email: PCNS@fda.hhs.gov. Further information regarding the please check https://www.fda.gov/ SUPPLEMENTARY INFORMATION: Pursuant AdvisoryCommittees/default.htm. most recent charter and other to 41 CFR 102–3.65 and approval by the information can be found at https:// Dated: June 5, 2018. Department of Health and Human www.fda.gov/AdvisoryCommittees/ Services pursuant to 45 CFR part 11 and Leslie Kux, CommitteesMeetingMaterials/Drugs/ by the General Services Administration, Associate Commissioner for Policy. PharmacyCompounding FDA is announcing the renewal of the [FR Doc. 2018–12443 Filed 6–8–18; 8:45 am] AdvisoryCommittee/ucm381305.htm or Peripheral and Central Nervous System BILLING CODE 4164–01–P by contacting the Designated Federal Drugs Advisory Committee. The Officer (see FOR FURTHER INFORMATION committee is a discretionary Federal CONTACT). In light of the fact that no advisory committee established to DEPARTMENT OF HEALTH AND change has been made to the committee provide advice to the Commissioner. HUMAN SERVICES name or description of duties, no The Peripheral and Central Nervous amendment will be made to 21 CFR Food and Drug Administration System Drugs Advisory Committee 14.100. advises the Commissioner or designee [Docket No. FDA–2018–P–0327] This document is issued under the in discharging responsibilities as they Federal Advisory Committee Act (5 relate to helping to ensure safe and Determination That MUTAMYCIN U.S.C. app.). For general information effective drugs for human use and, as (Mitomycin) Injectable, 5 Milligrams/ related to FDA advisory committees, required, any other product for which Vial and 20 Milligrams/Vial, Was Not please check https://www.fda.gov/ FDA has regulatory responsibility. Withdrawn From Sale for Reasons of AdvisoryCommittees/default.htm. The Committee reviews and evaluates Safety or Effectiveness Dated: June 5, 2018. data concerning the safety and AGENCY: Food and Drug Administration, Leslie Kux, effectiveness of marketed and HHS. Associate Commissioner for Policy. investigational human drug products for ACTION: Notice. [FR Doc. 2018–12440 Filed 6–8–18; 8:45 am] use in the treatment of neurologic diseases. SUMMARY: The Food and Drug BILLING CODE 4164–01–P The Committee shall consist of a core Administration (FDA or Agency) has of nine voting members including the determined that MUTAMYCIN DEPARTMENT OF HEALTH AND Chair. Members and the Chair are (mitomycin) injectable, 5 milligrams HUMAN SERVICES selected by the Commissioner or (mg)/vial and 20 mg/vial, was not designee from among authorities withdrawn from sale for reasons of Food and Drug Administration knowledgeable in the fields of safety or effectiveness. This neurology, neuropharmacology, determination will allow FDA to daltland on DSKBBV9HB2PROD with NOTICES [Docket No. FDA–2018–N–1725] neuropathology, otolaryngology, approve abbreviated new drug epidemiology or statistics, and related applications (ANDAs) for MUTAMYCIN Advisory Committee; Peripheral and specialties. Members will be invited to (mitomycin) injectable, 5 mg/vial and 20 Central Nervous System Drugs serve for overlapping terms of up to 4 mg/vial, if all other legal and regulatory Advisory Committee; Renewal years. Almost all non-Federal members requirements are met. AGENCY: Food and Drug Administration, of this committee serve as Special FOR FURTHER INFORMATION CONTACT: HHS. Government Employees. The core of Stacy Kane, Center for Drug Evaluation VerDate Sep<11>2014 19:19 Jun 08, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\11JNN1.SGM 11JNN1


Document Created: 2018-11-02 11:57:54
Document Modified: 2018-11-02 11:57:54
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; renewal of advisory committee.
DatesAuthority for the Pharmacy Compounding Advisory Committee will expire on April 25, 2020, unless the Commissioner formally determines that renewal is in the public interest.
ContactCindy Chee, 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, [email protected]
FR Citation83 FR 27009 
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