Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 48324-48325 [2015-19740]

Download as PDF 48324 Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices labels × 7.25 hours = 174 hours). In addition, 12 respondents will each spend 1 hour reading the guidance document, for a total of 12 hours. Thus, we estimate the total hour burden of the proposed collection of information to be 186 hours (174 hours + 12 hours = 186 hours). The guidance also refers to previously approved collections of information found in our regulations. The collections of information in §§ 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been approved under OMB control number 0910–0381. Allergen labeling of these beers under section 403(w)(1) of the FD&C Act, which was added by the Food Allergen Labeling and Consumer Protection Act of 2004, has been approved under OMB control number 0910–0792. 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 796–3110. SUPPLEMENTARY INFORMATION: Dated: August 6, 2015. Leslie Kux, Associate Commissioner for Policy. FDA is announcing the availability of a final guidance for industry entitled ‘‘Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ On November 27, 2013, President Obama signed the DQSA (Pub. L. 113– 54) into law. The DQSA added a new section 503B to the FD&C Act that created a category of entities called ‘‘outsourcing facilities.’’ Section 503B(d)(4) of the FD&C Act (21 U.S.C. 353b(d)(4)) defines an outsourcing facility, in part, as a facility that complies with all of the requirements of section 503B, including registering with FDA as an outsourcing facility and paying associated fees. If the conditions outlined in section 503B(a) of the FD&C Act are satisfied, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from certain sections of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and 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)). Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs). FDA has received questions about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility. Because entities that register as outsourcing facilities must pay a registration fee and FDA has determined [FR Doc. 2015–19741 Filed 8–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1399] Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled ‘‘Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:16 Aug 11, 2015 Jkt 235001 I. Background PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 that fees paid pursuant to sections 503B and 744K of the FD&C Act will not be refunded, FDA is issuing this guidance to answer some of these questions and to provide potential registrants additional information about the regulatory impact of registering as an outsourcing facility. In the Federal Register of February 19, 2015 (80 FR 8871), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on May 20, 2015. FDA received eleven comments on the draft guidance. Some of the comments raised issues that were not directly pertinent to the topics addressed in this guidance. FDA intends to consider those comments as they relate to issues being addressed in other policy documents being developed by the Agency. In response to received comments or on its own initiative, FDA made the following changes as it finalized this guidance: (1) Removed the reference to a separate guidance document that explains how outsourcing facilities should report the products they compound to FDA because that guidance is not directly related to the issue of entities considering whether to register as outsourcing facilities; (2) noted that FDA has issued separate guidance documents addressing some of the conditions of section 503B and that it intends to publish additional guidance addressing other conditions; (3) added a reference to FDA’s draft guidance regarding compounding animal drug products from bulk drug substances, which addresses outsourcing facilities engaging in this activity; and (4) made grammatical and other minor editorial changes for clarity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on registering as an outsourcing facility under section 503B of the FD&C Act. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: August 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–19740 Filed 8–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0882] Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date AGENCY: Food and Drug Administration, HHS. Notice; request for notification of intent to participate; extension of closing date. ACTION: The Food and Drug Administration (FDA) is extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA’s negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:16 Aug 11, 2015 Jkt 235001 by establishing consistent stakeholder representation. DATES: FDA is extending the closing date in the notice published June 3, 2015 (80 FR 31602). Submit notification of intent to participate by April 30, 2016. ADDRESSES: Submit notification of intent to participate in monthly stakeholder meetings by email to GenericDrugPolicy@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993–0002, 240– 402–7946, Connie.Wisner@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Introduction FDA is requesting that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify the Agency of their intent to participate in periodic consultation meetings on the reauthorization of GDUFA. GDUFA authorizes FDA to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities. GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements. The statutory authority for GDUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human generic drug review process. Section 744C(d) (21 U.S.C. 379j–43(d)) of the FD&C Act requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts. FDA initiated this process on June 15, 2015, by holding a public meeting at which stakeholders and other members of the public were given an opportunity to present their views on reauthorization (April 21, 2015, 80 FR 22204). The FD&C Act further requires that FDA continue meeting with these stakeholders at least once every month during negotiations with the regulated industry to continue discussions of stakeholder views on the reauthorization. FDA is issuing this Federal Register notice to request that stakeholder representatives from patient and consumer groups, health care PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 48325 professional associations, as well as scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on GDUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensuring progress in these discussions. If you wish to participate in this part of the reauthorization process, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions as needed. Stakeholders who identify themselves through this notice will be included in all stakeholder discussions while FDA negotiates with the regulated industry. Stakeholders who decide to participate in these monthly meetings at a later time may still participate in remaining monthly meetings by notifying FDA (see ADDRESSES). These stakeholder discussions will satisfy the requirement in section 744C(d)(3) of the FD&C Act. II. Notification of Intent To Participate in Periodic Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding GDUFA reauthorization, please provide notification by email to GenericDrugPolicy@fda.hhs.gov by April 30, 2016. Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting once FDA receives their notification. Dated: August 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–19768 Filed 8–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Pediatric 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 E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48324-48325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1399]


Guidance for Entities Considering Whether To Register as 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance entitled ``Guidance for Entities 
Considering Whether to Register as Outsourcing Facilities Under Section 
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is 
intended to inform entities that are considering registering as 
outsourcing facilities under section 503B of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), as added by the Drug Quality and 
Security Act (DQSA), of the regulatory implications of registration as 
an outsourcing facility.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Guidance for Entities Considering Whether to Register as 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.'' On November 27, 2013, President Obama signed the 
DQSA (Pub. L. 113-54) into law. The DQSA added a new section 503B to 
the FD&C Act that created a category of entities called ``outsourcing 
facilities.'' Section 503B(d)(4) of the FD&C Act (21 U.S.C. 353b(d)(4)) 
defines an outsourcing facility, in part, as a facility that complies 
with all of the requirements of section 503B, including registering 
with FDA as an outsourcing facility and paying associated fees. If the 
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a 
drug compounded by or under the direct supervision of a licensed 
pharmacist in an outsourcing facility is exempt from certain sections 
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) 
(concerning the labeling of drugs with adequate directions for use) and 
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)). Drugs compounded in outsourcing facilities are 
not exempt from the requirements of section 501(a)(2)(B) of the FD&C 
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing 
practice for drugs).
    FDA has received questions about whether entities engaged in 
various types of activities (e.g., a facility that is compounding only 
non-sterile drugs or only repackaging biological products) should 
register as an outsourcing facility. Because entities that register as 
outsourcing facilities must pay a registration fee and FDA has 
determined that fees paid pursuant to sections 503B and 744K of the 
FD&C Act will not be refunded, FDA is issuing this guidance to answer 
some of these questions and to provide potential registrants additional 
information about the regulatory impact of registering as an 
outsourcing facility.
    In the Federal Register of February 19, 2015 (80 FR 8871), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. The comment period on the draft guidance ended on May 
20, 2015. FDA received eleven comments on the draft guidance. Some of 
the comments raised issues that were not directly pertinent to the 
topics addressed in this guidance. FDA intends to consider those 
comments as they relate to issues being addressed in other policy 
documents being developed by the Agency.
    In response to received comments or on its own initiative, FDA made 
the following changes as it finalized this guidance: (1) Removed the 
reference to a separate guidance document that explains how outsourcing 
facilities should report the products they compound to FDA because that 
guidance is not directly related to the issue of entities considering 
whether to register as outsourcing facilities; (2) noted that FDA has 
issued separate guidance documents addressing some of the conditions of 
section 503B and that it intends to publish additional guidance 
addressing other conditions; (3) added a reference to FDA's draft 
guidance regarding compounding animal drug products from bulk drug 
substances, which addresses outsourcing facilities engaging in this 
activity; and (4) made grammatical and other minor editorial changes 
for clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on registering as an outsourcing facility 
under section 503B of the FD&C Act. It does not create any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division

[[Page 48325]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19740 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P

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