81 FR 65660 - Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 185 (September 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 185 (September 23, 2016)
| Page Range | 65660-65661 | |
| FR Document | 2016-22944 |
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)] [Notices] [Pages 65660-65661] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22944] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0881] Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry to meet the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-D-0881 for ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ [[Page 65661]] regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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. FOR FURTHER INFORMATION CONTACT: Andrew LeBoeuf, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0503. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' The guidance announced in this notice finalizes the draft guidance of the same name announced in the Federal Register of August 27, 2012 (77 FR 51811). Compared to the draft guidance, the final guidance clarifies various matters, including that the self- identification requirements have been implemented, and simplifies the instructions for electronic submission of self-identification information. FDA received one comment on the draft guidance, which was considered as the guidance was finalized. On July 9, 2012, GDUFA (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring owners of facilities producing generic drug products, active pharmaceutical ingredients (API), and certain other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA and update that information annually. Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Second, self-identification is a central component of an effort to promote global supply chain transparency. The information provided through self-identification enables quick, accurate, and reliable surveillance of generic drugs and facilitates inspections and compliance. Most facilities that self-identify are required to pay an annual facility user fee. These include facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs. Other facilities, sites, and organizations must self-identify, but are not required to pay the annual facility user fee. These include facilities that solely manufacture positron emission tomography drugs, or sites and organizations that only perform testing, repackaging, or relabeling operations. Please note that while re-packagers are not required to pay user fees, packagers are, in most cases, FDF manufacturers and subject to facility fees. A separate system for the electronic self-identification of generic industry facilities, sites, and organizations was established for GDUFA. Entities required to register and list (under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) or section 351 of the Public Health Service Act (42 U.S.C. 262)), and those required to self-identify under GDUFA, submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. The new GDUFA system uses the same platform and technical standards already familiar to manufacturers required to register and list. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' It does not establish 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. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: September 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22944 Filed 9-22-16; 8:45 am] BILLING CODE 4164-01-P
![65660 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
and Cosmetic Act (the FD&C Act) (21 DEPARTMENT OF HEALTH AND do not wish to be made available to the
U.S.C. 355(i)) became effective: June 23, HUMAN SERVICES public, submit the comment as a
2004. FDA has verified the Arena written/paper submission and in the
Pharmaceuticals, Inc. claim that June Food and Drug Administration manner detailed (see ‘‘Written/Paper
23, 2004, is the date the investigational [Docket No. FDA–2012–D–0881] Submissions’’ and ‘‘Instructions’’).
new drug application became effective. Written/Paper Submissions
2. The date the application was Self-Identification of Generic Drug
Facilities, Sites, and Organizations; Submit written/paper submissions as
initially submitted with respect to the follows:
Guidance for Industry; Availability
human drug product under section • Mail/Hand delivery/Courier (for
505(b) of the FD&C Act: December 22, AGENCY: Food and Drug Administration, written/paper submissions): Division of
2009. The applicant claims December HHS. Dockets Management (HFA–305), Food
18, 2009, as the date the NDA for ACTION: Notice of availability. and Drug Administration, 5630 Fishers
BELVIQ was initially submitted. Lane, Rm. 1061, Rockville, MD 20852.
However, FDA records indicate that SUMMARY: The Food and Drug • For written/paper comments
Administration (FDA or Agency) is submitted to the Division of Dockets
NDA 22–529 was submitted on
announcing the availability of a Management, FDA will post your
December 22, 2009.
guidance for industry entitled ‘‘Self- comment, as well as any attachments,
3. The date the application was Identification of Generic Drug Facilities, except for information submitted,
approved: June 27, 2012. FDA has Sites, and Organizations.’’ On July 9, marked and identified, as confidential,
verified the applicant’s claim that NDA 2012, the Generic Drug User Fee if submitted as detailed in
22–529 was approved on June 27, 2012. Amendments of 2012 (GDUFA) was ‘‘Instructions.’’
FDA has verified the applicant’s claim signed into law by the President. Instructions: All submissions received
that NDA 22–529 was approved on June GDUFA, designed to speed the delivery must include the Docket No. FDA–
27, 2012. of safe and effective generic drugs to the 2012–D–0881 for ‘‘Self-Identification of
This determination of the regulatory public and reduce costs to industry, Generic Drug Facilities, Sites, and
review period establishes the maximum requires that generic drug facilities, Organizations.’’ Received comments
potential length of a patent extension. sites, and organizations around the will be placed in the docket and, except
However, the USPTO applies several world provide identification for those submitted as ‘‘Confidential
statutory limitations in its calculations information annually to FDA. This Submissions,’’ publicly viewable at
guidance is intended to assist industry http://www.regulations.gov or at the
of the actual period for patent extension.
to meet the self-identification Division of Dockets Management
In its applications for patent extension,
requirement. It explains who is required between 9 a.m. and 4 p.m., Monday
this applicant seeks 1,174 days; 1,051
to self-identify, what information must through Friday.
days; or 352 days of patent term • Confidential Submissions—To
be requested, how the information
extension, respectively. should be submitted to FDA, and what submit a comment with confidential
III. Petitions the penalty is for failure to self-identify. information that you do not wish to be
DATES: Submit either electronic or made publicly available, submit your
Anyone with knowledge that any of written comments on Agency guidances comments only as a written/paper
the dates as published are incorrect may at any time. submission. You should submit two
submit either electronic or written ADDRESSES: You may submit comments copies total. One copy will include the
comments and ask for a redetermination as follows: information you claim to be confidential
(see DATES). Furthermore, any interested with a heading or cover note that states
person may petition FDA for a Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
determination regarding whether the Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
applicant for extension acted with due following way: Agency will review this copy, including
diligence during the regulatory review • Federal eRulemaking Portal: http:// the claimed confidential information, in
period. To meet its burden, the petition www.regulations.gov. Follow the its consideration of comments. The
must be timely (see DATES) and contain instructions for submitting comments. second copy, which will have the
sufficient facts to merit an FDA Comments submitted electronically, claimed confidential information
investigation. (See H. Rept. 857, part 1, including attachments, to http:// redacted/blacked out, will be available
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to for public viewing and posted on http://
Petitions should be in the format the docket unchanged. Because your www.regulations.gov. Submit both
comment will be made public, you are copies to the Division of Dockets
specified in 21 CFR 10.30.
solely responsible for ensuring that your Management. If you do not wish your
Submit petitions electronically to comment does not include any name and contact information to be
http://www.regulations.gov at Docket confidential information that you or a made publicly available, you can
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, provide this information on the cover
petitions (two copies are required) to the such as medical information, your or sheet and not in the body of your
Division of Dockets Management (HFA– anyone else’s Social Security number, or comments and you must identify this
305), Food and Drug Administration, confidential business information, such information as ‘‘confidential.’’ Any
5630 Fishers Lane, Rm. 1061, Rockville, information marked as ‘‘confidential’’
sradovich on DSK3GMQ082PROD with NOTICES
as a manufacturing process. Please note
MD 20852. that if you include your name, contact will not be disclosed except in
Dated: September 19, 2016. information, or other information that accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
Leslie Kux,
comments, that information will be information about FDA’s posting of
Associate Commissioner for Policy. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
[FR Doc. 2016–22937 Filed 9–22–16; 8:45 am] • If you want to submit a comment 56469, September 18, 2015, or access
BILLING CODE 4164–01–P with confidential information that you the information at: http://www.fda.gov/
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![Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices 65661
regulatoryinformation/dockets/ products to electronically self-identify RegulatoryInformation/Guidances/
default.htm. with FDA and update that information default.htm or http://
Docket: For access to the docket to annually. www.regulations.gov.
read background documents or the Self-identification is required for two Dated: September 19, 2016.
electronic and written/paper comments purposes. First, it is necessary to
Leslie Kux,
received, go to http:// determine the universe of facilities
required to pay user fees. Second, self- Associate Commissioner for Policy.
www.regulations.gov and insert the
identification is a central component of [FR Doc. 2016–22944 Filed 9–22–16; 8:45 am]
docket number, found in brackets in the
heading of this document, into the an effort to promote global supply chain BILLING CODE 4164–01–P
‘‘Search’’ box and follow the prompts transparency. The information provided
and/or go to the Division of Dockets through self-identification enables
Management, 5630 Fishers Lane, Rm. quick, accurate, and reliable DEPARTMENT OF HEALTH AND
1061, Rockville, MD 20852. surveillance of generic drugs and HUMAN SERVICES
Submit written requests for single facilitates inspections and compliance.
Most facilities that self-identify are Indian Health Service
copies of this guidance to the Division
of Drug Information, Center for Drug required to pay an annual facility user Notice of Tribal Consultation and
Evaluation and Research, Food and fee. These include facilities Urban Confer Sessions on the State of
Drug Administration, 10001 New manufacturing, or intending to the Great Plains Area Indian Health
Hampshire Ave., Hillandale Building, manufacture, API of human generic
Service; Extension of Comment Period
4th Floor, Silver Spring, MD 20993– drugs and/or finished dosage form (FDF)
0002. Send one self-addressed adhesive human generic drugs. Other facilities, AGENCY: Indian Health Service, HHS.
label to assist that office in processing sites, and organizations must self- ACTION: Notice; extension of comment
your requests. See the SUPPLEMENTARY identify, but are not required to pay the period.
INFORMATION section for electronic annual facility user fee. These include
facilities that solely manufacture SUMMARY: This document extends the
access to the guidance document.
positron emission tomography drugs, or comment period in the Notice of Tribal
FOR FURTHER INFORMATION CONTACT: Consultation and Urban Confer Sessions
sites and organizations that only
Andrew LeBoeuf, Center for Drug perform testing, repackaging, or on the State of the Great Plains Area
Evaluation and Research, Food and relabeling operations. Please note that Indian Health Service announcement
Drug Administration, 10903 New while re-packagers are not required to that was published in the Federal
Hampshire Ave., Silver Spring, MD pay user fees, packagers are, in most Register on June 3, 2016.
20993, 240–402–0503. cases, FDF manufacturers and subject to DATES: The comment period has been
SUPPLEMENTARY INFORMATION: facility fees. extended to November 30, 2016.
I. Background A separate system for the electronic FOR FURTHER INFORMATION CONTACT:
self-identification of generic industry Roselyn Tso, Acting Director, Office of
FDA is announcing the availability of facilities, sites, and organizations was Direct Service and Contracting Tribes,
a guidance for industry entitled ‘‘Self- established for GDUFA. Entities Indian Health Service, 5600 Fishers
Identification of Generic Drug Facilities, required to register and list (under Lane, Mail Stop 08E17, Rockville, MD
Sites, and Organizations.’’ The guidance section 510 of the Federal Food, Drug, 20857, telephone (301) 443–1104. (This
announced in this notice finalizes the and Cosmetic Act (21 U.S.C. 360) or is not a toll-free number.)
draft guidance of the same name section 351 of the Public Health Service
announced in the Federal Register of Dated: September 16, 2016.
Act (42 U.S.C. 262)), and those required
August 27, 2012 (77 FR 51811). to self-identify under GDUFA, submit Mary Smith,
Compared to the draft guidance, the information separately to the respective Principal Deputy Director, Indian Health
final guidance clarifies various matters, systems. Each system populates its own Service.
including that the self-identification database to meet unique requirements [FR Doc. 2016–22922 Filed 9–22–16; 8:45 am]
requirements have been implemented, and deadlines. The new GDUFA system BILLING CODE 4165–16–P
and simplifies the instructions for uses the same platform and technical
electronic submission of self- standards already familiar to
identification information. FDA manufacturers required to register and DEPARTMENT OF HEALTH AND
received one comment on the draft list. HUMAN SERVICES
guidance, which was considered as the This guidance is being issued
guidance was finalized. National Institutes of Health
consistent with FDA’s good guidance
On July 9, 2012, GDUFA (Pub. L. 112– practices regulation (21 CFR 10.115). National Institute of Allergy and
144, Title III) was signed into law by the The guidance represents the current Infectious Diseases; Notice of Closed
President. GDUFA is designed to speed thinking of FDA on ‘‘Self-Identification Meeting
the delivery of safe and effective generic of Generic Drug Facilities, Sites, and
drugs to the public and reduce costs to Organizations.’’ It does not establish any Pursuant to section 10(d) of the
industry. GDUFA enables FDA to assess rights for any person and is not binding Federal Advisory Committee Act, as
user fees to support critical and on FDA or the public. You can use an amended (5 U.S.C. App.), notice is
measurable enhancements to FDA’s alternative approach if it satisfies the hereby given of the following meeting.
generic drugs program. GDUFA will also The meeting will be closed to the
sradovich on DSK3GMQ082PROD with NOTICES
requirements of the applicable statutes
significantly improve global supply and regulations. public in accordance with the
chain transparency by requiring owners provisions set forth in sections
of facilities producing generic drug II. Electronic Access 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
products, active pharmaceutical Persons with access to the Internet as amended. The grant applications and
ingredients (API), and certain other sites may obtain the guidance at either http:// the discussions could disclose
and organizations that support the www.fda.gov/Drugs/ confidential trade secrets or commercial
manufacture or approval of these GuidanceCompliance property such as patentable material,
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Document Created: 2016-09-23 01:43:49
Document Modified: 2016-09-23 01:43:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Andrew LeBoeuf, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0503. | |
| FR Citation | 81 FR 65660 |
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