83 FR 17556 - Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 77 (April 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17556-17557 | |
| FR Document | 2018-08252 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Notices] [Pages 17556-17557] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08252] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1176] Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; 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 final guidance for industry entitled ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance addresses questions about implementation of FDA's guidance ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients'' (ICH Q7). The Q&A guidance is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all active pharmaceutical ingredients (APIs) meet the standards for quality and purity they purport or are represented to possess. DATES: The announcement of the guidance is published in the Federal Register on April 20, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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-2018-D-1176 for ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 [[Page 17557]] 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: Alicia Mozzachio, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3308, Silver Spring, MD 20993-0002, 301- 796-3206; or Anna Flynn, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 5070, Silver Spring, MD 20993-0002, 240-402-9156. 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 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 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 also 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 ICH member and observer. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance. A final draft of the guidance was submitted to the ICH Assembly and endorsed by the regulatory agencies in June 2015. The guidance provides clarification on the implementation of good manufacturing practices for APIs, as described in ICH Q7. 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 ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.'' 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 guidance 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: April 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-08252 Filed 4-19-18; 8:45 am] BILLING CODE 4164-01-P
![17556 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
participants and beneficiaries receive DEPARTMENT OF HEALTH AND information, or other information that
written notice of such revocation from HUMAN SERVICES identifies you in the body of your
the issuer or third party administrator in comments, that information will be
accordance with guidance issued by the Food and Drug Administration posted on https://www.regulations.gov.
Secretary, and if the accommodation [Docket No. FDA–2018–D–1176]
• If you want to submit a comment
process is currently being utilized, such with confidential information that you
revocation will be effective on the first Q7 Good Manufacturing Practice do not wish to be made available to the
day of the first plan year that begins on Guidance for Active Pharmaceutical public, submit the comment as a
Ingredients: Questions and Answers; written/paper submission and in the
or after thirty days after the date of
International Council for manner detailed (see ‘‘Written/Paper
revocation.
Harmonisation; Guidance for Industry; Submissions’’ and ‘‘Instructions’’).
Final rules were published in the Availability
Federal Register on July 14, 2015 (80 FR Written/Paper Submissions
41318) under which qualifying closely AGENCY: Food and Drug Administration, Submit written/paper submissions as
held, for-profit entities may avail HHS. follows:
themselves of the accommodation to ACTION: Notice of availability. • Mail/Hand Delivery/Courier (for
effectively exempt their plans from the written/paper submissions): Dockets
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
otherwise applicable requirement to Administration (FDA or Agency) is Drug Administration, 5630 Fishers
cover certain contraceptive services. announcing the availability of a final Lane, Rm. 1061, Rockville, MD 20852.
Previously, this accommodation had guidance for industry entitled ‘‘Q7 Good • For written/paper comments
been available only to non-profit eligible Manufacturing Practice Guidance for submitted to the Dockets Management
organizations. These final rules also Active Pharmaceutical Ingredients: Staff, FDA will post your comment, as
finalized the 2014 interim final rules Questions and Answers.’’ The guidance well as any attachments, except for
permit an eligible organization to notify was prepared under the auspices of the information submitted, marked and
HHS directly that it will not contract, International Council for Harmonisation identified, as confidential, if submitted
arrange, pay, or refer for all or a subset (ICH), formerly the International as detailed in ‘‘Instructions.’’
of contraceptive services. Conference on Harmonisation. This Instructions: All submissions received
Due to judicial decisions question and answer (Q&A) guidance must include the Docket No. FDA–
preliminarily enjoining the addresses questions about 2018–D–1176 for ‘‘Q7 Good
implementation of the 2017 interim implementation of FDA’s guidance ‘‘Q7 Manufacturing Practice Guidance for
Good Manufacturing Practice Guidance Active Pharmaceutical Ingredients:
final regulations, the information
for Active Pharmaceutical Ingredients’’ Questions and Answers; International
collection requirements are drafted to be
(ICH Q7). The Q&A guidance is Council for Harmonisation; Guidance
applicable under whichever intended to clarify uncertainties due to for Industry; Availability.’’ Received
accommodation rules are in effect (for the interpretation of certain sections of comments will be placed in the docket
example, the 2017 interim final rules, or ICH Q7 and to help ensure that all and, except for those submitted as
the 2015 final rules if the 2017 interim active pharmaceutical ingredients (APIs) ‘‘Confidential Submissions,’’ publicly
final rules continue to be enjoined). meet the standards for quality and viewable at https://www.regulations.gov
HHS will only implement the ICRs purity they purport or are represented to or at the Dockets Management Staff
under regulations that are legally in possess. between 9 a.m. and 4 p.m., Monday
effect at the time the ICRs are used. DATES: The announcement of the through Friday.
Form Number: CMS–10653 (OMB guidance is published in the Federal • Confidential Submissions—To
control number: 0938–1344); Frequency: Register on April 20, 2018. submit a comment with confidential
On Occasion; Affected Public: Private ADDRESSES: You may submit either information that you do not wish to be
Sector; Number of Respondents: 110; electronic or written comments on made publicly available, submit your
Number of Responses: 110; Total Agency guidances at any time as comments only as a written/paper
Annual Hours: 181. (For policy follows: submission. You should submit two
questions regarding this collection, copies total. One copy will include the
contact Usree Bandyopadhyay at 410– Electronic Submissions information you claim to be confidential
786–6650.) Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
Dated: April 17, 2018. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
William N. Parham, III, https://www.regulations.gov. Follow the Agency will review this copy, including
Director, Paperwork Reduction Staff, Office instructions for submitting comments. the claimed confidential information, in
of Strategic Operations and Regulatory Comments submitted electronically, its consideration of comments. The
Affairs. including attachments, to https:// second copy, which will have the
[FR Doc. 2018–08329 Filed 4–19–18; 8:45 am] www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4120–01–P the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
sradovich on DSK3GMQ082PROD with NOTICES
confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
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![Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices 17557
as ‘‘confidential’’ will not be disclosed the world have participated in many establish any rights for any person and
except in accordance with 21 CFR 10.20 important initiatives to promote is not binding on FDA or the public.
and other applicable disclosure law. For international harmonization of You can use an alternative approach if
more information about FDA’s posting regulatory requirements under ICH. it satisfies the requirements of the
of comments to public dockets, see 80 FDA has participated in several ICH applicable statutes and regulations. This
FR 56469, September 18, 2015, or access meetings designed to enhance guidance is not subject to Executive
the information at: https://www.gpo.gov/ harmonization, and FDA is committed Order 12866.
fdsys/pkg/FR-2015-09-18/pdf/2015- to seeking scientifically based
harmonized technical procedures for II. Electronic Access
23389.pdf.
Docket: For access to the docket to pharmaceutical development. One of Persons with access to the internet
read background documents or the the goals of harmonization is to identify may obtain the guidance at https://
electronic and written/paper comments and reduce differences in technical www.regulations.gov, https://
received, go to https:// requirements for drug development www.fda.gov/Drugs/Guidance
www.regulations.gov and insert the among regulatory agencies. ComplianceRegulatoryInformation/
docket number, found in brackets in the ICH was established to provide an Guidances/default.htm, or https://
heading of this document, into the opportunity for harmonization www.fda.gov/BiologicsBloodVaccines/
‘‘Search’’ box and follow the prompts initiatives to be developed with input GuidanceComplianceRegulatory
and/or go to the Dockets Management from both regulatory and industry Information/Guidances/default.htm.
Staff, 5630 Fishers Lane, Rm. 1061, representatives. FDA also seeks input Dated: April 13, 2018.
Rockville, MD 20852. from consumer representatives and
Leslie Kux,
You may submit comments on any others. ICH is concerned with
harmonization of technical Associate Commissioner for Policy.
guidance at any time (see 21 CFR
requirements for the registration of [FR Doc. 2018–08252 Filed 4–19–18; 8:45 am]
10.115(g)(5)).
Submit written requests for single pharmaceutical products for human use BILLING CODE 4164–01–P
copies of this guidance to the Division among regulators around the world. The
of Drug Information, Center for Drug six founding members of ICH are the
European Commission; the European DEPARTMENT OF HEALTH AND
Evaluation and Research, Food and
Federation of Pharmaceutical Industries HUMAN SERVICES
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, Associations; FDA; the Japanese
Ministry of Health, Labour, and Welfare; Health Resources and Services
4th Floor, Silver Spring, MD 20993– Administration
0002, or the Office of Communication, the Japanese Pharmaceutical
Outreach and Development, Center for Manufacturers Association; and the National Advisory Council on Nurse
Biologics Evaluation and Research Pharmaceutical Research and Education and Practice
(CBER), Food and Drug Administration, Manufacturers of America. The
10903 New Hampshire Ave., Bldg. 71, Standing Members of the ICH AGENCY: Health Resources and Services
Rm. 3128, Silver Spring, MD 20993– Association also include Health Canada Administration (HRSA), Department of
0002. Send one self-addressed adhesive and Swissmedic. Any party eligible as a Health and Human Services (HHS).
label to assist that office in processing Member in accordance with the ICH ACTION: Notice of Federal Advisory
your requests. The guidance may also be Articles of Association can apply for Committee meeting.
obtained by mail by calling CBER at 1– membership in writing to the ICH
800–835–4709 or 240–402–8010. See Secretariat. The ICH Secretariat, which SUMMARY: In accordance with the
the SUPPLEMENTARY INFORMATION section coordinates the preparation of Federal Advisory Committee Act, this
for electronic access to the guidance documentation, operates as an notice announces that the National
document. international nonprofit organization and Advisory Council on Nurse Education
is funded by the Members of the ICH and Practice (NACNEP) will hold a
FOR FURTHER INFORMATION CONTACT: Association. public meeting.
Regarding the guidance: Alicia The ICH Assembly is the overarching DATES: Wednesday, May 16, 2018, from
Mozzachio, Center for Drug Evaluation body of the Association and includes 11:00 a.m. to 4:00 p.m. ET.
and Research, Food and Drug representatives from each ICH member
Administration, 10903 New Hampshire ADDRESSES: This meeting is a
and observer. The Assembly is
Ave., Bldg. 51, Rm. 3308, Silver Spring, teleconference and webinar. The
responsible for the endorsement of draft
MD 20993–0002, 301–796–3206; or conference call-in number is 1–800–
guidelines and adoption of final
Anna Flynn, Center for Biologics 619–2521 and the passcode is 9271697.
guidelines. FDA publishes ICH
Evaluation and Research, Food and The webinar link is https://
guidelines as FDA guidance.
Drug Administration, 10903 New A final draft of the guidance was hrsa.connectsolutions.com/nacnep/.
Hampshire Ave., Bldg. 71, Rm. 5070, submitted to the ICH Assembly and FOR FURTHER INFORMATION CONTACT:
Silver Spring, MD 20993–0002, 240– endorsed by the regulatory agencies in Anyone requesting information
402–9156. June 2015. The guidance provides regarding the NACNEP meeting should
Regarding the ICH: Amanda Roache, clarification on the implementation of contact CDR Antoine Smith, Designated
Center for Drug Evaluation and good manufacturing practices for APIs, Federal Official (DFO), Bureau of Health
Research, Food and Drug as described in ICH Q7. Workforce (BHW), HRSA, in one of
Administration, 10903 New Hampshire This guidance is being issued three ways: (1) Send a request to the
sradovich on DSK3GMQ082PROD with NOTICES
Ave., Bldg. 51, Rm. 1176, Silver Spring, consistent with FDA’s good guidance following address: CDR Antoine Smith,
MD 20993–0002, 301–796–4548. practices regulation (21 CFR 10.115). DFO, BHW, HRSA, 5600 Fishers Lane,
SUPPLEMENTARY INFORMATION: The guidance represents the current Room 11N120, Rockville, Maryland
thinking of FDA on ‘‘Q7 Good 20857; (2) call 301–443–3726; or (3)
I. Background Manufacturing Practice Guidance for send an email to asmith@hrsa.gov.
In recent years, regulatory authorities Active Pharmaceutical Ingredients: SUPPLEMENTARY INFORMATION: NACNEP
and industry associations from around Questions and Answers.’’ It does not provides advice and recommendations
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Document Created: 2018-04-20 00:03:06
Document Modified: 2018-04-20 00:03:06
| 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 | The announcement of the guidance is published in the Federal Register on April 20, 2018. | |
| Contact | Regarding the guidance: Alicia Mozzachio, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3308, Silver Spring, MD 20993-0002, 301- 796-3206; or Anna Flynn, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 5070, Silver Spring, MD 20993-0002, 240-402-9156. | |
| FR Citation | 83 FR 17556 |
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