Pharmacy Compounding Advisory Committee; Notice of Meeting, 29717-29719 [2015-12512]

Download as PDF 29717 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Section 111.75(a)(1) (21 CFR 111.75(a)(1)) establishes a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. Under § 111.75(a)(1)(ii), manufacturers may request an exemption from the requirements set forth in § 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in the petition. The regulation clarifies that we are willing to consider, on a case-bycase basis, a manufacturer’s conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use. Section 111.75(a)(1) reflects our determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, we added to § 111.75(a)(1) an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the Agency for such an exemption to 100 percent identity testing under § 10.30 (21 CFR 10.30)and the Agency grants such exemption. Such a procedure would be consistent with our stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. Section 111.75(a)(1)(ii) sets forth the information a manufacturer is required to submit in such a petition. The regulation also contains a requirement to ensure that the manufacturer keeps our response to a petition submitted under § 111.75(a)(1)(ii) as a record under § 111.95. The collection of information in § 111.95 has been approved under OMB control number 0910–0606. Description of Respondents: The respondents to this collection of information are firms in the dietary supplement industry, including dietary supplement manufacturers, packagers and re-packagers, holders, labelers and re-labelers, distributors, warehouses, exporters, importers, large businesses, and small businesses. In the Federal Register of March 9, 2015 (80 FR 12491), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received, but was not responsive to the four collection of information topics solicited in the notice and, therefore, is not discussed in this document. We estimate the annual burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section; CGMP requirements for dietary supplements Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 111.75(a)(1)(ii) ..................................................................... 1 1 1 8 8 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In the last 3 years, we have not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients; therefore, the Agency estimates that one or fewer petitions will be submitted annually. Based on our experience with petition processes, we estimate it will take a requestor about 8 hours to prepare the factual and legal information necessary to support a petition for exemption and to prepare the petition. Although we have not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients in the last 3 years, we believe that OMB approval of these information collection provisions should be extended to provide for the potential future need of a firm in the dietary supplement industry to petition for an exemption from 100 percent identity testing of dietary ingredients. VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 Dated: May 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12398 Filed 5–21–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Pharmacy Compounding Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pharmacy Compounding Advisory Committee. PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 General Function of the Committee: To provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. Date and Time: The meeting will be held on June 17, 2015, from 8:30 a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.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: https://www.fda.gov/ AdvisoryCommittees/ E:\FR\FM\22MYN1.SGM 22MYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 29718 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Jayne E. Peterson, 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: PCAC@ fda.hhs.gov, 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 https:// 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. Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). The Drug Quality and Security Act adds a new section, 503B, to the FD&C Act (21 U.S.C. 353b) that creates a new category of ‘‘outsourcing facilities.’’ Outsourcing facilities, as defined in section 503B of the FD&C Act, are facilities that meet certain conditions described in section 503B, including registration with FDA as an outsourcing facility. If these conditions are satisfied, a drug product compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee–1), but not section 501(a)(2)(B). One of the conditions that must be satisfied to qualify for the exemptions under both sections 503A and 503B of the FD&C Act is that the drug that is compounded does not appear on a list published by the Secretary of drugs that VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (‘‘withdrawn or removed list’’) (see sections 503A(b)(1)(C) and 503B(a)(4) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list (‘‘section 503A bulk drug substances list’’) developed by the Secretary through regulations issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the compounded drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product (see section 503A(b)(3)(A) of the FD&C Act). Another condition that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act is that the compounded drug is not identified (directly or as part of a category of drugs) on a list published by the Secretary of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients, or the drug is compounded in accordance with all applicable conditions that are necessary to prevent the drug or category of drugs from presenting such demonstrable difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act). FDA will discuss with the committee drugs proposed for inclusion on the withdrawn or removed list pursuant to sections 503A and 503B and on the section 503A bulk drug substances list. FDA will also discuss with the committee the criteria FDA proposes to PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 use to evaluate candidates to be identified as difficult to compound pursuant to sections 503A and 503B. Agenda: On June 17, 2015, during the morning session, the committee will receive updates on certain issues to follow up on discussions from the last meeting including the options for obtaining access to investigational new drugs and the processes FDA plans to use to add or remove drugs from the section 503A bulk drug substances list. During this session, the committee will also discuss revisions FDA is considering to the list of drug products that may not be compounded under the exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The list of those drug products is currently codified at 21 CFR 216.24. FDA now is considering whether to amend the rule to add four more drugs to the list: Aprotinin, ondansetron hydrochloride, bromocriptine mesylate, and acetaminophen. As previously explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 through 37690), the list may specify that a drug may not be compounded in any form, or, alternatively, may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list because an approved drug containing the same active ingredient(s) has not been withdrawn or removed from the market. Moreover, a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms because it has been found to be unsafe or not effective in those particular formulations, indications, routes of administration, or dosage forms. FDA plans to seek the committee’s advice concerning the inclusion of these drug products. On June 17, 2015, during the afternoon session, the committee will discuss four bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: Brilliant Blue G, tranilast, N-acetyl-Dglucosamine, and oxitriptan. The nominators of these substances will be invited to make a short presentation supporting the nomination. Other nominated substances will be discussed at future committee meetings. During the morning session on June 18, 2015, the committee will discuss the criteria FDA is proposing to use to evaluate drug products or categories of E:\FR\FM\22MYN1.SGM 22MYN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices drug products for identification as demonstrably difficult to compound. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: 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 June 9, 2015. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17, 2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18, 2015. 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 June 4, 2015. 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 June 8, 2015. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jayne E. Peterson 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 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 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: May 19, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015–12512 Filed 5–21–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0639] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: On December 3, 2014, the Agency submitted a proposed collection of information entitled ‘‘Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0569. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00118 Fmt 4703 Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12399 Filed 5–21–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0781] BILLING CODE 4164–01–P AGENCY: 29719 Sfmt 4703 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 22, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0428. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE–14526, Silver Spring, MD 20993–0002 PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health SUMMARY: Claim—21 CFR 101.82(c)(2)(ii)(B) OMB Control Number 0910–0428— Extension Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29717-29719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12512]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee.
    General Function of the Committee: To provide advice on scientific, 
technical, and medical issues concerning drug compounding under 
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), and, as required, any other product for which FDA has 
regulatory responsibility, and make appropriate recommendations to the 
Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on June 17, 2015, from 8:30 
a.m. to 5 p.m., and on June 18, 2015, from 8:30 a.m. to 11:30 a.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: https://www.fda.gov/
AdvisoryCommittees/

[[Page 29718]]

AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Jayne E. Peterson, 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: PCAC@fda.hhs.gov, 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 https://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.
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes 
the conditions that must be satisfied for human drug products 
compounded by a licensed pharmacist or licensed physician to be exempt 
from the following three sections of the FD&C Act: (1) Section 
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good 
manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) 
(concerning the labeling of drugs with adequate directions for use); 
and (3) section 505 (21 U.S.C. 355) (concerning the approval of human 
drug products under new drug applications (NDAs) or abbreviated new 
drug applications (ANDAs)).
    The Drug Quality and Security Act adds a new section, 503B, to the 
FD&C Act (21 U.S.C. 353b) that creates a new category of ``outsourcing 
facilities.'' Outsourcing facilities, as defined in section 503B of the 
FD&C Act, are facilities that meet certain conditions described in 
section 503B, including registration with FDA as an outsourcing 
facility. If these conditions are satisfied, a drug product compounded 
for human use by or under the direct supervision of a licensed 
pharmacist in an outsourcing facility is exempt from three sections of 
the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 
582 (21 U.S.C. 360eee-1), but not section 501(a)(2)(B).
    One of the conditions that must be satisfied to qualify for the 
exemptions under both sections 503A and 503B of the FD&C Act is that 
the drug that is compounded does not appear on a list published by the 
Secretary of drugs that have been withdrawn or removed from the market 
because such drug products or components of such drug products have 
been found to be unsafe or not effective (``withdrawn or removed 
list'') (see sections 503A(b)(1)(C) and 503B(a)(4) of the FD&C Act).
    Another condition that must be satisfied to qualify for the 
exemptions under section 503A of the FD&C Act is that a bulk drug 
substance (active pharmaceutical ingredient) used in a compounded drug 
must meet one of the following criteria: (1) Complies with the 
standards of an applicable United States Pharmacopoeia (USP) or 
National Formulary monograph, if a monograph exists, and the USP 
chapter on pharmacy compounding; (2) if an applicable monograph does 
not exist, is a component of a drug approved by the Secretary of Health 
and Human Services (the Secretary); or (3) if such a monograph does not 
exist and the drug substance is not a component of a drug approved by 
the Secretary, appears on a list (``section 503A bulk drug substances 
list'') developed by the Secretary through regulations issued by the 
Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the 
exemptions under section 503A of the FD&C Act is that the compounded 
drug product is not a drug product identified by the Secretary by 
regulation as a drug product that presents demonstrable difficulties 
for compounding that reasonably demonstrate an adverse effect on the 
safety or effectiveness of that drug product (see section 503A(b)(3)(A) 
of the FD&C Act).
    Another condition that must be satisfied to qualify for the 
exemptions in section 503B of the FD&C Act is that the compounded drug 
is not identified (directly or as part of a category of drugs) on a 
list published by the Secretary of drugs or categories of drugs that 
present demonstrable difficulties for compounding that are reasonably 
likely to lead to an adverse effect on the safety or effectiveness of 
the drug or category of drugs, taking into account the risks and 
benefits to patients, or the drug is compounded in accordance with all 
applicable conditions that are necessary to prevent the drug or 
category of drugs from presenting such demonstrable difficulties (see 
section 503B(a)(6)(A) and (B) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on 
the withdrawn or removed list pursuant to sections 503A and 503B and on 
the section 503A bulk drug substances list. FDA will also discuss with 
the committee the criteria FDA proposes to use to evaluate candidates 
to be identified as difficult to compound pursuant to sections 503A and 
503B.
    Agenda: On June 17, 2015, during the morning session, the committee 
will receive updates on certain issues to follow up on discussions from 
the last meeting including the options for obtaining access to 
investigational new drugs and the processes FDA plans to use to add or 
remove drugs from the section 503A bulk drug substances list. During 
this session, the committee will also discuss revisions FDA is 
considering to the list of drug products that may not be compounded 
under the exemptions provided by the FD&C Act because the drug products 
have been withdrawn or removed from the market because such drug 
products or components of such drug products have been found to be 
unsafe or not effective. The list of those drug products is currently 
codified at 21 CFR 216.24. FDA now is considering whether to amend the 
rule to add four more drugs to the list: Aprotinin, ondansetron 
hydrochloride, bromocriptine mesylate, and acetaminophen. As previously 
explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 
through 37690), the list may specify that a drug may not be compounded 
in any form, or, alternatively, may expressly exclude a particular 
formulation, indication, dosage form, or route of administration from 
an entry on the list because an approved drug containing the same 
active ingredient(s) has not been withdrawn or removed from the market. 
Moreover, a drug may be listed only with regard to certain 
formulations, indications, routes of administration, or dosage forms 
because it has been found to be unsafe or not effective in those 
particular formulations, indications, routes of administration, or 
dosage forms. FDA plans to seek the committee's advice concerning the 
inclusion of these drug products.
    On June 17, 2015, during the afternoon session, the committee will 
discuss four bulk drug substances nominated for inclusion on the 
section 503A bulk drug substances list. FDA intends to discuss the 
following nominated bulk drug substances: Brilliant Blue G, tranilast, 
N-acetyl-D-glucosamine, and oxitriptan. The nominators of these 
substances will be invited to make a short presentation supporting the 
nomination. Other nominated substances will be discussed at future 
committee meetings.
    During the morning session on June 18, 2015, the committee will 
discuss the criteria FDA is proposing to use to evaluate drug products 
or categories of

[[Page 29719]]

drug products for identification as demonstrably difficult to compound.
    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: 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 June 
9, 2015. Oral presentations from the public will be scheduled between 
approximately 11 a.m. to 11:15 a.m. and 3:45 p.m. to 4 p.m. on June 17, 
2015, and between approximately 9:15 a.m. to 9:45 a.m. on June 18, 
2015. 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 June 
4, 2015. 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 June 8, 2015.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Jayne E. Peterson 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 https://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: May 19, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-12512 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P
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