80 FR 54566 - International Conference on Harmonisation; Guidance on Q3D Elemental Impurities; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 175 (September 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 175 (September 10, 2015)
| Page Range | 54566-54567 | |
| FR Document | 2015-22835 |
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)] [Notices] [Pages 54566-54567] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22835] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1156] International Conference on Harmonisation; Guidance on Q3D Elemental Impurities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q3D Elemental Impurities.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance establishes permitted daily exposures for 24 elements in drug products based on evaluation of toxicity data. Permitted daily exposures are provided for each element by three routes of administration--oral, parenteral and inhalation. The guidance also provides for a risk-based approach to assessing the likelihood that elemental impurities with established permitted daily exposures will be present in a pharmaceutical product. The guidance is intended to provide a harmonized approach to control of elemental impurities in pharmaceutical products in order to avoid the uncertainty and duplication of work that results from different requirements in different ICH regions. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://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: Regarding the guidance: John Kauffman, Center for Drug Evaluation and Research, Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO 63110, 314-539-2168; Regarding the ICH: Michelle Limoli, CBER International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7212, Silver Spring, MD 20993-0002, 301-796-8377. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. [[Page 54567]] In the Federal Register of October 23, 2013 (78 FR 63219), FDA published a notice announcing the availability of a draft guidance entitled ``Q3D Elemental Impurities.'' The notice gave interested persons an opportunity to submit comments by December 23, 2013. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies on December 16, 2014. The guidance establishes permitted daily exposures for 24 elements in drug products and provides for a risk-based approach to assessing the likelihood that elemental impurities with established permitted daily exposures will be present in a pharmaceutical product. In response to comments on the draft guidance, several changes were made to the final guidance including clarifying the scope, reevaluation of some permitted daily exposures based on new toxicology data, simplification of the classification scheme for elemental impurities, and clarifying the examples to illustrate certain concepts within the guidance. 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 Q3D elemental impurities. It does 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. Comments Interested persons may submit either electronic comments regarding this document to http://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 of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: September 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-22835 Filed 9-9-15; 8:45 am] BILLING CODE 4164-01-P
![54566 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
an exception to the prohibition against DEPARTMENT OF HEALTH AND Submit written comments to the
expansion of facility capacity. As HUMAN SERVICES Division of Dockets Management (HFA–
required by the November 30, 2011final 305), Food and Drug Administration,
rule and our public guidance Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville,
documents, HBC submitted the data and [Docket No. FDA–2013–D–1156] MD 20852.
certifications necessary to demonstrate FOR FURTHER INFORMATION CONTACT:
that it satisfies the criteria to qualify as International Conference on Regarding the guidance: John Kauffman,
a high Medicaid facility. In accordance Harmonisation; Guidance on Q3D Center for Drug Evaluation and
with section 1877(i)(3) of the Act, we Elemental Impurities; Availability Research, Food and Drug
have granted HBC’s request for an Administration, 645 S. Newstead Ave.,
exception to the expansion of facility AGENCY: Food and Drug Administration, St. Louis, MO 63110, 314–539–2168;
capacity prohibition based on the HHS. Regarding the ICH: Michelle Limoli,
following criteria: ACTION: Notice. CBER International Programs, Food and
• HBC is not the sole hospital in Vigo, SUMMARY: The Food and Drug Drug Administration, 10903 New
Indiana, the county in which it is Administration (FDA) is announcing the Hampshire Ave., Bldg. 71, Rm. 7212,
located; availability of a guidance entitled ‘‘Q3D Silver Spring, MD 20993–0002, 301–
Elemental Impurities.’’ The guidance 796–8377.
• HBC certified that it does not SUPPLEMENTARY INFORMATION:
discriminate against beneficiaries of was prepared under the auspices of the
Federal health care programs and does International Conference on I. Background
not permit physicians practicing at the Harmonisation of Technical
Requirements for Registration of In recent years, many important
hospital to discriminate against such initiatives have been undertaken by
beneficiaries; and Pharmaceuticals for Human Use (ICH).
The guidance establishes permitted regulatory authorities and industry
• With respect to each of the 3 most daily exposures for 24 elements in drug associations to promote international
recent fiscal years for which data were products based on evaluation of toxicity harmonization of regulatory
available as of the date HBC submitted data. Permitted daily exposures are requirements. FDA has participated in
its request, it has an annual percentage provided for each element by three many meetings designed to enhance
of total inpatient admissions under routes of administration—oral, harmonization and is committed to
Medicaid that is estimated to be greater parenteral and inhalation. The guidance seeking scientifically based harmonized
than such percentage with respect to also provides for a risk-based approach technical procedures for pharmaceutical
such admissions for any other hospital to assessing the likelihood that development. One of the goals of
located in Vigo County, Indiana, the elemental impurities with established harmonization is to identify and then
county in which it is located. permitted daily exposures will be reduce differences in technical
present in a pharmaceutical product. requirements for drug development
Our approval grants HBC’s request to among regulatory agencies.
add a total of 44 beds. Pursuant to The guidance is intended to provide a
ICH was organized to provide an
§ 411.362(c)(6), the expansion may harmonized approach to control of
opportunity for tripartite harmonization
occur only in facilities on the hospital’s elemental impurities in pharmaceutical
initiatives to be developed with input
main campus and may not result in the products in order to avoid the
from both regulatory and industry
number of operating rooms, procedure uncertainty and duplication of work
representatives. FDA also seeks input
rooms, and beds for which HBC is that results from different requirements
from consumer representatives and
licensed to exceed 200 percent of its in different ICH regions.
others. ICH is concerned with
baseline number of operating rooms, DATES: Submit either electronic or harmonization of technical
procedure rooms, and beds. HBC written comments on Agency guidances requirements for the registration of
certified that its baseline number of at any time. pharmaceutical products among three
operating rooms, procedure rooms, and ADDRESSES: Submit written requests for regions: The European Union, Japan,
beds is 44. Accordingly, we find that single copies of the guidance to the and the United States. The six ICH
granting an additional 44 beds will not Division of Drug Information (HFD– sponsors are the European Commission;
exceed the limitation on a permitted 240), Center for Drug Evaluation and the European Federation of
expansion. Research, Food and Drug Pharmaceutical Industries Associations;
Administration, 10001 New Hampshire the Japanese Ministry of Health, Labour,
IV. Collection of Information
Ave., Hillandale Building, 4th Floor, and Welfare; the Japanese
Requirements
Silver Spring, MD 20993, or the Office Pharmaceutical Manufacturers
This document does not impose of Communication, Outreach and Association; the Centers for Drug
information collection requirements, Development, Center for Biologics Evaluation and Research and Biologics
that is, reporting, recordkeeping or Evaluation and Research (CBER), Food Evaluation and Research, FDA; and the
third-party disclosure requirements. and Drug Administration, 10903 New Pharmaceutical Research and
Consequently, there is no need for Hampshire Ave., Bldg. 71, Rm. 3128, Manufacturers of America. The ICH
review by the Office of Management and Silver Spring, MD 20993–0002. Send Secretariat, which coordinates the
Budget under the authority of the one self-addressed adhesive label to preparation of documentation, is
Paperwork Reduction Act of 1995 (44 assist the office in processing your provided by the International
mstockstill on DSK4VPTVN1PROD with NOTICES
U.S.C. 3501 et seq.). requests. The guidance may also be Federation of Pharmaceutical
obtained by mail by calling CBER at 1– Manufacturers Associations (IFPMA).
Dated: August 18, 2015.
800–835–4709 or 240–402–7800. See The ICH Steering Committee includes
Andrew M. Slavitt, the SUPPLEMENTARY INFORMATION section representatives from each of the ICH
Acting Administrator, Centers for Medicare for electronic access to the guidance sponsors and the IFPMA, as well as
& Medicaid Services. document. observers from the World Health
[FR Doc. 2015–22856 Filed 9–9–15; 8:45 am] Submit electronic comments on the Organization, Health Canada, and the
BILLING CODE 4120–01–P guidance to http://www.regulations.gov. European Free Trade Area.
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![Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices 54567
In the Federal Register of October 23, RegulatoryInformation/Guidances/ Ave., Bldg. 22, Rm. 5379, Silver Spring,
2013 (78 FR 63219), FDA published a default.htm. MD 20993–0002, 301–796–9687, email:
notice announcing the availability of a Dated: September 4, 2015. Samantha.Bell@fda.hhs.gov.
draft guidance entitled ‘‘Q3D Elemental Leslie Kux, SUPPLEMENTARY INFORMATION:
Impurities.’’ The notice gave interested
Associate Commissioner for Policy. I. Background
persons an opportunity to submit
[FR Doc. 2015–22835 Filed 9–9–15; 8:45 am] FDA is announcing a public
comments by December 23, 2013.
BILLING CODE 4164–01–P workshop entitled ‘‘Osteoporosis Drug
After consideration of the comments
received and revisions to the guidance, Development: Moving Forward.’’ The
a final draft of the guidance was Agency will engage experts in
DEPARTMENT OF HEALTH AND osteoporosis to address challenging
submitted to the ICH Steering
HUMAN SERVICES issues related to osteoporosis drug
Committee and endorsed by the three
participating regulatory agencies on Food and Drug Administration development. Workshop sessions will
December 16, 2014. include discussions on the indication
The guidance establishes permitted [Docket No. FDA–2015–N–3172] language, target populations for
daily exposures for 24 elements in drug treatment and prevention of
Osteoporosis Drug Development; osteoporosis, and phase 3 clinical trial
products and provides for a risk-based
Public Workshop; Request for design issues. The afternoon discussion
approach to assessing the likelihood
Comments session will focus on surrogate
that elemental impurities with
established permitted daily exposures AGENCY: Food and Drug Administration, endpoints for fracture and the
will be present in a pharmaceutical HHS. requirements for validation of a
product. In response to comments on surrogate endpoint. This workshop is
ACTION: Notice of public workshop;
the draft guidance, several changes were part of the Agency’s program to
request for comments.
made to the final guidance including facilitate the development of surrogate
clarifying the scope, reevaluation of The Food and Drug Administration’s endpoints, clinical endpoints, and other
some permitted daily exposures based (FDA or Agency) Division of Bone, scientific methods for predicting
on new toxicology data, simplification Reproductive, and Urologic Products in clinical benefit, in accordance with
of the classification scheme for the Center for Drug Evaluation and section 901 of the Food and Drug
elemental impurities, and clarifying the Research is announcing a public Administration Safety and Innovation
examples to illustrate certain concepts workshop entitled ‘‘Osteoporosis Drug Act, signed into law on July 9, 2012,
within the guidance. Development: Moving Forward.’’ The which is titled ‘‘Enhancement of
This guidance is being issued purpose of this workshop is to seek Accelerated Patient Access to New
consistent with FDA’s good guidance input from experts on scientific issues Medical Treatments.’’
practices regulation (21 CFR 10.115). important to clinical development of II. Participation in the Public
The guidance represents the current drugs and therapeutic biologics Workshop
thinking of FDA on Q3D elemental intended to treat osteoporosis. During
impurities. It does establish any rights the workshop, attendees will discuss A. Registration and Requests for Oral
for any person and is not binding on potential surrogate endpoints and the Presentations
FDA or the public. You can use an endpoints’ ability to predict clinical There is no fee to attend the public
alternative approach if it satisfies the benefit. workshop, but attendees should register
requirements of the applicable statutes Date and Time: The workshop will be in advance. Space is limited and
and regulations. held on November 4, 2015, from 8 a.m. registration will be on a first-come, first-
to 5 p.m. Registration to attend the served basis. Persons interested in
II. Comments
workshop must be received by October attending this workshop must register
Interested persons may submit either 21, 2015. See the SUPPLEMENTARY online at Osteoporosis_Workshop@
electronic comments regarding this INFORMATION section for information on fda.hhs.gov on or before October 21,
document to http://www.regulations.gov how to register for this workshop. 2015. When registering, please provide
or written comments to the Division of Submit electronic or written comments complete contact information for each
Dockets Management (see ADDRESSES). It by October 7, 2015. attendee, including name, title,
is only necessary to send one set of Location: The workshop will be held affiliation, address, email address, and
comments. Identify comments with the at the FDA White Oak Campus, 10903 telephone number. For those without
docket number found in brackets in the New Hampshire Ave., Bldg. 31 Internet access, please contact Samantha
heading of this document. Received Conference Center, in Sections B and C Bell (see Contact Person) to register. If
comments may be seen in the Division of the Great Room (Rm. 1503), Silver you need special accommodations due
of Dockets Management between 9 a.m. Spring, MD 20993–0002. Entrance for to a disability, please contact Samantha
and 4 p.m., Monday through Friday, and the workshop participants (non-FDA Bell (see Contact Person) at least 7 days
will be posted to the docket at http:// employees) is through Building 1, where in advance.
www.regulations.gov. routine security check procedures will The afternoon session will have an
be performed. For more information on open public hearing. Interested persons
III. Electronic Access
parking and security procedures, please may present data, information, or views,
mstockstill on DSK4VPTVN1PROD with NOTICES
Persons with access to the Internet refer to http://www.fda.gov/AboutFDA/ orally or in writing, on issues related to
may obtain the document at http:// WorkingatFDA/BuildingsandFacilities/ osteoporosis drug development. Those
www.regulations.gov, http:// WhiteOakCampusInformation/ individuals interested in making formal
www.fda.gov/Drugs/Guidance ucm241740.htm. oral presentations should notify the
ComplianceRegulatoryInformation/ Contact Person: Samantha Bell, contact person and submit the following
Guidances/default.htm, or http:// Center for Drug Evaluation and information on or before October 21,
www.fda.gov/BiologicsBloodVaccines/ Research, Food and Drug 2015: A brief statement of the general
GuidanceCompliance Administration, 10903 New Hampshire nature of the evidence or arguments
VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1](https://thefederalregister.org/doc/80_FR_54741/page/2.svg)
Document Created: 2015-12-15 10:03:53
Document Modified: 2015-12-15 10:03:53
| 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. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Regarding the guidance: John Kauffman, Center for Drug Evaluation and Research, Food and Drug Administration, 645 S. Newstead Ave., St. Louis, MO 63110, 314-539-2168; | |
| FR Citation | 80 FR 54566 |
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