83 FR 32669 - Q3D(R1) Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 135 (July 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 135 (July 13, 2018)
| Page Range | 32669-32670 | |
| FR Document | 2018-14971 |
[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)] [Notices] [Pages 32669-32670] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14971] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1156] Q3D(R1) Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Q3D(R1) Elemental Impurities.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance revises the existing ICH guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms ([micro]g)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. The draft guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure. Following deliberations within the Q3D Expert Working Group, the revised calculation is based on a modifying factor approach that is consistent with the oral and parenteral PDE calculations. DATES: Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2013-D-1156 for ``Q3D(R1) Elemental Impurities.'' Received comments will be placed in the docket and, except for [[Page 32670]] those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, 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 that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Tim McGovern, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6300, Silver Spring, MD 20993- 0002, 240-402-0477. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. ICH was established to provide an opportunity for 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 for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance. In May 2018, the ICH Assembly endorsed the draft guideline entitled ``Q3D(R1) Elemental Impurities'' and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Quality Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Quality Expert Working Group. The draft guidance revises the existing guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The revision was initiated following identification of a calculation error in the original text. The updated PDE of 3 [micro]g/day is based on a modifying factor approach that is consistent with the method used for calculating the PDEs for the oral and parenteral routes of exposure. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Q3D(R1) Elemental Impurities.'' 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the document at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: July 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14971 Filed 7-12-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32669
allow CMS to obtain more information legitimate physicians, non-physician in the PDE for cadmium by the
about who is submitting requests for practitioners, and other eligible inhalation route of exposure. Following
ODR and whether the service or claim professionals are enrolled in the deliberations within the Q3D Expert
is being provided by a contract or non- Medicare program. It is meant to be the Working Group, the revised calculation
contract provider. The timeliness first line defense to protect our is based on a modifying factor approach
requirement for ODR will also be beneficiaries from illegitimate providers that is consistent with the oral and
eliminated to be consistent with Part D and to protect the Medicare Trust Fund parenteral PDE calculations.
reporting. In addition, the number of against fraud. It also gathers information DATES: Submit either electronic or
data reporting elements of grievances is that allows Medicare contractors to written comments on the draft guidance
reduced from 23 to 19. The reporting ensure that the provider/supplier is not by August 13, 2018 to ensure that the
sections for Private Fee For Service sanctioned from the Medicare and/or Agency considers your comment on this
(PFFS) Payment Dispute Resolution Medicaid program(s), or debarred, draft guidance before it begins work on
Process and Mid-Year Network Changes suspended or excluded from any other the final version of the guidance.
will also be suspended. Form Number: Federal agency or program. Form
ADDRESSES: You may submit comments
CMS–10261 (OMB control number: Number: CMS–855i (OMB control
on any guidance at any time as follows:
0938–1054); Frequency: Yearly and number: 0938–NEW); Frequency: On
semi-annually; Affected Public: Private Occasion; Affected Public: State, Local, Electronic Submissions
sector (business or other for-profits); or Tribal Governments, Private Sector
Submit electronic comments in the
Number of Respondents: 432; Total (not-for-profit institutions); Number of
following way:
Annual Responses: 3,024; Total Annual Respondents: 513,872; Total Annual
• Federal eRulemaking Portal:
Hours: 127,329. (For policy questions Responses: 1,370,078; Total Annual
https://www.regulations.gov. Follow the
regarding this collection contact Maria Hours: 1,000,167. For policy questions
instructions for submitting comments.
Sotirelis at 410–786–0552.) regarding this collection contact
6. Type of Information Collection Comments submitted electronically,
Kimberly McPhillips at (410)-786–5374.
Request: Revision of a currently including attachments, to https://
Dated: July 10, 2018. www.regulations.gov will be posted to
approved collection; Title of
William N. Parham, III, the docket unchanged. Because your
Information Collection: Consumer
Director, Paperwork Reduction Staff, Office comment will be made public, you are
Assessment of Healthcare Providers and of Strategic Operations and Regulatory
Systems Outpatient and Ambulatory solely responsible for ensuring that your
Affairs. comment does not include any
Surgery (OAS CAHPS) Survey; Use: The
[FR Doc. 2018–15038 Filed 7–12–18; 8:45 am] confidential information that you or a
information collected in the national
implementation of Outpatient/ BILLING CODE 4120–01–P third party may not wish to be posted,
Ambulatory Surgery Patient Experience such as medical information, your or
of Care Survey (A/ASPECS) will be used anyone else’s Social Security number, or
DEPARTMENT OF HEALTH AND confidential business information, such
to: (1) Provide a source of information HUMAN SERVICES
from which selected measures can be as a manufacturing process. Please note
publicly reported to beneficiaries to that if you include your name, contact
Food and Drug Administration
help them make informed decisions for information, or other information that
outpatient surgery facility selection; (2) [Docket No. FDA–2013–D–1156] identifies you in the body of your
aid facilities with their internal quality comments, that information will be
Q3D(R1) Elemental Impurities; posted on https://www.regulations.gov.
improvement efforts and external International Council for
benchmarking with other facilities; and • If you want to submit a comment
Harmonisation; Draft Guidance for with confidential information that you
(3) provide us with information for Industry; Availability
monitoring and public reporting do not wish to be made available to the
purposes. Form Number: CMS–10500 AGENCY: Food and Drug Administration, public, submit the comment as a
(OMB control number: 0938–1240); HHS. written/paper submission and in the
Frequency: Once; Affected Public: ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper
Individuals and households; Number of Submissions’’ and ‘‘Instructions’’).
Respondents: 633,304; Total Annual SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions
Responses: 633,304; Total Annual
Hours: 153,592. (For policy questions announcing the availability of a draft Submit written/paper submissions as
regarding this collection contact guidance for industry entitled ‘‘Q3D(R1) follows:
Memuna Ifedirah at 410–786–6849). Elemental Impurities.’’ The draft • Mail/Hand delivery/Courier (for
7. Type of Information Collection guidance was prepared under the written/paper submissions): Dockets
Request: New collection (Request for auspices of the International Council for Management Staff (HFA–305), Food and
new OMB control number); Title of Harmonisation (ICH), formerly the Drug Administration, 5630 Fishers
Information Collection: Medicare International Conference on Lane, Rm. 1061, Rockville, MD 20852.
Enrollment Application for Physician Harmonisation. The draft guidance • For written/paper comments
and Non-Physician Practitioners; Use: revises the existing ICH guidance for submitted to the Dockets Management
The application is used by Medicare industry ‘‘Q3D Elemental Impurities’’ Staff, FDA will post your comment, as
contractors to collect data to ensure that and provides an updated permitted well as any attachments, except for
daily exposure (PDE) for the cadmium information submitted, marked and
sradovich on DSK3GMQ082PROD with NOTICES
the applicant has the necessary
credentials to provide the health care inhalation route of exposure. The identified, as confidential, if submitted
services for which they intend to bill updated PDE of 3 micrograms (mg)/day as detailed in ‘‘Instructions.’’
Medicare, including information that is based on a modifying factor approach Instructions: All submissions received
allows the Medicare contractor to like that used for calculating the PDEs must include the Docket No. FDA–
correctly price, process and pay the for the cadmium oral and parenteral 2013–D–1156 for ‘‘Q3D(R1) Elemental
applicant’s claims. This application routes of exposure. The draft guidance Impurities.’’ Received comments will be
collects information to ensure that only is intended to correct a calculation error placed in the docket and, except for
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![32670 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices
those submitted as ‘‘Confidential 0002. Send one self-addressed adhesive documentation, operates as an
Submissions,’’ publicly viewable at label to assist that office in processing international nonprofit organization and
https://www.regulations.gov or at the your requests. The guidance may also be is funded by the Members of the ICH
Dockets Management Staff office obtained by mail by calling CBER at 1– Association.
between 9 a.m. and 4 p.m., Monday 800–835–4709 or 240–402–8010. See The ICH Assembly is the overarching
through Friday. the SUPPLEMENTARY INFORMATION section
• Confidential Submissions—To body of the Association and includes
for electronic access to the guidance
submit a comment with confidential representatives from each of the ICH
document.
information that you do not wish to be members and observers. The Assembly
FOR FURTHER INFORMATION CONTACT: is responsible for the endorsement of
made publicly available, submit your
Regarding the guidance: Tim McGovern, draft guidelines and adoption of final
comments only as a written/paper
Center for Drug Evaluation and guidelines. FDA publishes ICH
submission. You should submit two
Research, Food and Drug guidelines as FDA guidance.
copies total. One copy will include the
Administration, 10903 New Hampshire
information you claim to be confidential In May 2018, the ICH Assembly
Ave., Bldg. 22, Rm. 6300, Silver Spring,
with a heading or cover note that states endorsed the draft guideline entitled
‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 240–402–0477.
Regarding the ICH: Amanda Roache, ‘‘Q3D(R1) Elemental Impurities’’ and
CONFIDENTIAL INFORMATION.’’ The agreed that the guideline should be
Center for Drug Evaluation and
Agency will review this copy, including made available for public comment. The
Research, Food and Drug
the claimed confidential information, in draft guideline is the product of the
Administration, 10903 New Hampshire
its consideration of comments. The Quality Expert Working Group of the
Ave., Bldg. 51, Rm. 1176, Silver Spring,
second copy, which will have the
MD 20993–0002, 301–796–4548. ICH. Comments about this draft will be
claimed confidential information
SUPPLEMENTARY INFORMATION: considered by FDA and the Quality
redacted/blacked out, will be available
for public viewing and posted on Expert Working Group.
I. Background
https://www.regulations.gov. Submit The draft guidance revises the
both copies to the Dockets Management In recent years, regulatory authorities existing guidance for industry ‘‘Q3D
Staff. If you do not wish your name and and industry associations from around Elemental Impurities’’ and provides an
contact information to be made publicly the world have participated in many updated permitted daily exposure (PDE)
available, you can provide this important initiatives to promote for the cadmium inhalation route of
information on the cover sheet and not international harmonization of
exposure. The revision was initiated
in the body of your comments and you regulatory requirements under the ICH.
following identification of a calculation
must identify this information as FDA has participated in several ICH
error in the original text. The updated
‘‘confidential.’’ Any information marked meetings designed to enhance
harmonization and FDA is committed to PDE of 3 mg/day is based on a modifying
as ‘‘confidential’’ will not be disclosed factor approach that is consistent with
except in accordance with 21 CFR 10.20 seeking scientifically based harmonized
technical procedures for pharmaceutical the method used for calculating the
and other applicable disclosure law. For PDEs for the oral and parenteral routes
more information about FDA’s posting development. One of the goals of
harmonization is to identify and reduce of exposure.
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access differences in technical requirements for This draft guidance is being issued
the information at: https://www.gpo.gov/ drug development among regulatory consistent with FDA’s good guidance
fdsys/pkg/FR-2015-09-18/pdf/2015- agencies. practices regulation (21 CFR 10.115).
23389.pdf. ICH was established to provide an The draft guidance, when finalized, will
Docket: For access to the docket to opportunity for harmonization represent the current thinking of FDA
read background documents or the initiatives to be developed with input on ‘‘Q3D(R1) Elemental Impurities.’’ It
electronic and written/paper comments from both regulatory and industry does not establish any rights for any
received, go to https:// representatives. FDA also seeks input person and is not binding on FDA or the
www.regulations.gov and insert the from consumer representatives and public. You can use an alternative
docket number, found in brackets in the others. ICH is concerned with approach if it satisfies the requirements
heading of this document, into the harmonization of technical of the applicable statutes and
‘‘Search’’ box and follow the prompts requirements for the registration of regulations. This guidance is not subject
and/or go to the Dockets Management pharmaceutical products for human use to Executive Order 12866.
Staff, 5630 Fishers Lane, Rm. 1061, among regulators around the world. The
Rockville, MD 20852. six founding members of the ICH are the II. Electronic Access
You may submit comments on any European Commission; the European
guidance at any time (see 21 CFR Federation of Pharmaceutical Industries Persons with access to the internet
10.115(g)(5)). Associations; FDA; the Japanese may obtain the document at https://
Submit written requests for single Ministry of Health, Labour, and Welfare; www.regulations.gov, https://
copies of this guidance to the Division the Japanese Pharmaceutical www.fda.gov/Drugs/Guidance
of Drug Information, Center for Drug Manufacturers Association; and the ComplianceRegulatoryInformation/
Evaluation and Research, Food and Pharmaceutical Research and Guidances/default.htm, or https://
Drug Administration, 10001 New Manufacturers of America. The www.fda.gov/BiologicsBloodVaccines/
Hampshire Ave., Hillandale Building, Standing Members of the ICH GuidanceComplianceRegulatory
sradovich on DSK3GMQ082PROD with NOTICES
4th Floor, Silver Spring, MD 20993– Association include Health Canada and Information/Guidances/default.htm.
0002, or the Office of Communication, Swissmedic. Any party eligible as a Dated: July 9, 2018.
Outreach and Development, Center for Member in accordance with the ICH
Leslie Kux,
Biologics Evaluation and Research Articles of Association can apply for
(CBER), Food and Drug Administration, membership in writing to the ICH Associate Commissioner for Policy.
10903 New Hampshire Ave., Bldg. 71, Secretariat. The ICH Secretariat, which [FR Doc. 2018–14971 Filed 7–12–18; 8:45 am]
Rm. 3128, Silver Spring, MD 20993– coordinates the preparation of BILLING CODE 4164–01–P
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Document Created: 2018-07-13 01:04:12
Document Modified: 2018-07-13 01:04:12
| 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 the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Regarding the guidance: Tim McGovern, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6300, Silver Spring, MD 20993- 0002, 240-402-0477. | |
| FR Citation | 83 FR 32669 |
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