81 FR 22281 - Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 73 (April 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22281-22283 | |
| FR Document | 2016-08683 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Pages 22281-22283] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08683] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1113] Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Integrity and Compliance With CGMP.'' The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements. [[Page 22282]] DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 14, 2016. 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-2016-D-1113 for ``Data Integrity and Compliance With CGMP.'' 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/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 the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg, 4th Floor, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 4244, Silver Spring, MD 20993-0002, 301- 796-3191; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Pl., Rm.130, Rockville, MD 20855, 240-402-5623. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Data Integrity and Compliance With CGMP.'' Increased CGMP violations involving data integrity observed in recent CGMP inspections have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The purpose of this draft guidance is to clarify the role of data integrity in CGMP for drugs, as required in 21 CFR parts 210, 211, and 212. The draft guidance addresses specific questions about how data integrity relates to compliance with CGMP for drugs, as well as more general data integrity concepts, in question and answer format. Parts of this draft guidance have been previously published on the FDA Web site in Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance--Records and Reports (Q&A Level 2 guidance). When finalized, this draft guidance will replace the Q&A Level 2 guidance on data integrity in CGMP. 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 data integrity and compliance with CGMP. 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. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by [[Page 22283]] the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 210 and 211 (CGMPs), 212 (PET CGMPs), and 21 CFR part 11 (electronic records and signatures) have been approved under OMB control numbers 0910-0139, 0910-0667, and 0910-0303, respectively. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov. Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08683 Filed 4-14-16; 8:45 am] BILLING CODE 4164-01-P
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accordance with 21 CFR 10.20 and other and/or hospital facilities to ensure 19, 2016, will be provided to the
applicable disclosure law. For more patient safety during surgical committee. Comments received after
information about FDA’s posting of procedures where these devices are that date will be taken into
comments to public dockets, see 80 FR used; and (4) appropriate guidelines consideration by the Agency.
56469, September 18, 2015, or access and/or criteria based on a risk For press inquiries, please contact the
the information at: http://www.fda.gov/ stratification schema for notifying Office of Media Affairs at fdaoma@
regulatoryinformation/dockets/ patients who may have already been fda.hhs.gov or 301–796–4540.
default.htm. exposed to NTM during prior cardiac FDA welcomes the attendance of the
Docket: For access to the docket to surgeries. Recommendations on these public at its advisory committee
read background documents or the issues will assist FDA in minimizing meetings and will make every effort to
electronic and written/paper comments patient exposure to infections that may accommodate persons with disabilities.
received, go to http:// result from contaminated heater-cooler If you require accommodations due to a
www.regulations.gov and insert the devices. disability, please contact AnnMarie
docket number, found in brackets in the FDA intends to make background Williams, at AnnMarie.Williams@
heading of this document, into the material available to the public no later fda.hhs.gov, or 301–796–5966, at least 7
‘‘Search’’ box and follow the prompts than 2 business days before the meeting. days in advance of the meeting.
and/or go to the Division of Dockets If FDA is unable to post the background FDA is committed to the orderly
Management, 5630 Fishers Lane, Rm. material on its Web site prior to the conduct of its advisory committee
1061, Rockville, MD 20852. meeting, the background material will meetings. Please visit our Web site at
FOR FURTHER INFORMATION CONTACT: be made publicly available at the http://www.fda.gov/
Evella Washington, Center for Devices location of the advisory committee AdvisoryCommittees/
and Radiological Health, Food and Drug meeting, and the background material AboutAdvisoryCommittees/
Administration, 10903 New Hampshire will be posted on FDA’s Web site after ucm111462.htm for procedures on
Ave., Bldg. 66, Rm. 1535, Silver Spring, the meeting. Background material is public conduct during advisory
MD 20993–0002, 301–796–5290, available at http://www.fda.gov/ committee meetings.
Evella.Washington@fda.hhs.gov, or FDA AdvisoryCommittees/Calendar/ Notice of this meeting is given under
Advisory Committee Information Line, default.htm. Scroll down to the the Federal Advisory Committee Act (5
1–800–741–8138 (301–443–0572 in the appropriate advisory committee meeting U.S.C. app. 2).
Washington, DC area). A notice in the link.
Procedure: Interested persons may Dated: April 12, 2016.
Federal Register about last minute Jill Hartzler Warner,
modifications that impact a previously present data, information, or views,
announced advisory committee meeting orally or in writing, on issues pending Associate Commissioner for Special Medical
before the committee. Written Programs.
cannot always be published quickly
enough to provide timely notice. submissions may be made to the contact [FR Doc. 2016–08737 Filed 4–14–16; 8:45 am]
Therefore, you should always check the person on or before May 19, 2016. Oral BILLING CODE 4164–01–P
presentations from the public will be
Agency’s Web site at http://
scheduled between approximately 1
www.fda.gov/AdvisoryCommittees/
p.m. and 2 p.m. on June 2, 2016, and DEPARTMENT OF HEALTH AND
default.htm and scroll down to the
between approximately 9 a.m. and 10 HUMAN SERVICES
appropriate advisory committee meeting
a.m. on June 3, 2016. Those individuals
link, or call the advisory committee Food and Drug Administration
interested in making formal oral
information line to learn about possible
presentations should notify the contact
modifications before coming to the [Docket No. FDA–2016–D–1113]
person and submit a brief statement of
meeting.
the general nature of the evidence or Data Integrity and Compliance With
SUPPLEMENTARY INFORMATION: arguments they wish to present, the Current Good Manufacturing Practice;
Agenda: On June 2 and 3, 2016, the names and addresses of proposed Draft Guidance for Industry;
committee will discuss recent reports participants, and an indication of the Availability
and epidemiologic investigations of approximate time requested to make
nontuberculous mycobacteria (NTM) their presentation on or before May 11, AGENCY: Food and Drug Administration,
infections associated with the use of 2016. Time allotted for each HHS.
heater-cooler devices during cardiac presentation may be limited. If the ACTION: Notice of availability.
surgical procedures. FDA is convening number of registrants requesting to
this committee to seek expert scientific speak is greater than can be reasonably SUMMARY: The Food and Drug
and clinical opinion related to accommodated during the scheduled Administration (FDA or Agency) is
contamination of heater-cooler devices, open public hearing session, FDA may announcing the availability of a draft
associated patient infections, and conduct a lottery to determine the guidance for industry entitled ‘‘Data
mitigation strategies based on available speakers for the scheduled open public Integrity and Compliance With CGMP.’’
scientific information. The committee hearing session. The contact person will The purpose of the draft guidance is to
will make recommendations on: (1) The notify interested persons regarding their clarify the role of data integrity in
effectiveness of cleaning and request to speak by May 12, 2016. current good manufacturing practice
disinfection methods for heater-cooler Persons attending FDA’s advisory (CGMP) for drugs. The draft guidance is
asabaliauskas on DSK3SPTVN1PROD with NOTICES
devices; (2) the amount and type of committee meetings are advised that the in response to an increase in CGMP
premarket data and information needed Agency is not responsible for providing violations involving data integrity
to demonstrate validation of cleaning access to electrical outlets. observed in recent CGMP inspections.
and disinfection of heater-cooler devices FDA is establishing a docket for When finalized, the draft guidance is
in support of labeling claims and public comment on this document. The intended to provide the Agency’s
technical instructions; (3) appropriate docket number is FDA–2016–N–1126. current thinking on the creation and
risk mitigations to be implemented by The docket will close on June 16, 2016. handling of data in accordance with
manufacturers of heater-cooler devices Comments received on or before May CGMP requirements.
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![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22283
the Office of Management and Budget Dated: April 11, 2016. approval of 8 new drug applications
(OMB) under the Paperwork Reduction Leslie Kux, (NDAs) and 46 abbreviated new drug
Act of 1995 (44 U.S.C. 3501–3520). The Associate Commissioner for Policy. applications (ANDAs) for prescription
collections of information in 21 CFR [FR Doc. 2016–08683 Filed 4–14–16; 8:45 am] pain medications containing
parts 210 and 211 (CGMPs), 212 (PET BILLING CODE 4164–01–P
propoxyphene from multiple applicants.
CGMPs), and 21 CFR part 11 (electronic The document failed to withdraw
records and signatures) have been approval of NDA 017507, held by
approved under OMB control numbers DEPARTMENT OF HEALTH AND Xanodyne Pharmaceuticals, Inc.
0910–0139, 0910–0667, and 0910–0303, HUMAN SERVICES (Xanodyne). Xanodyne wrote to FDA
respectively. asking the Agency to withdraw approval
Food and Drug Administration of NDA 017507 and waiving its
III. Electronic Access [Docket No. FDA–2014–N–0198] opportunity for a hearing. FDA confirms
the withdrawal of approval of NDA
Persons with access to the Internet 017507.
Xanodyne Pharmaceuticals, Inc., et al.;
may obtain the document at either
Withdrawal of Approval of 8 New Drug FOR FURTHER INFORMATION CONTACT:
http://www.fda.gov/Drugs/Guidance Applications and 46 Abbreviated New
ComplianceRegulatoryInformation/ David Joy, Center for Drug Evaluation
Drug Applications for Propoxyphene and Research, Food and Drug
Guidances/default.htm, http:// Products; Correction Administration, 10903 New Hampshire
www.fda.gov/BiologicsBloodVaccines/
AGENCY: Food and Drug Administration, Ave., Bldg. 51, Rm. 6254, Silver Spring,
GuidanceComplianceRegulatory
HHS. MD 20993–0002, 301–796–3601.
Information/default.htm, http://
www.fda.gov/AnimalVeterinary/ ACTION: Notice; correction. SUPPLEMENTARY INFORMATION: In the
GuidanceComplianceEnforcement/ Federal Register of Monday, March 10,
GuidanceforIndustry/default.htm, or SUMMARY: The Food and Drug 2014, FR Doc. 2014–05063, on page
Administration (FDA) is correcting a 13308, the following correction is made:
http://www.regulations.gov.
notice that appeared in the Federal On page 13308, in table 1, the
Register of March 10, 2014 (79 FR following entry is added in numerical
13308). The document withdrew order by Application No.:
Application No. Drug Applicant or holder
NDA 017507 ...... Darvocet-N 100 (propoxyphene napsylate and acetamino- Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., New-
phen) Suspension, 100 milligrams (mg)/650 mg/15 milli- port, KY 41071.
liters.
Dated: April 11, 2016. announced the availability of a guidance comment does not include any
Leslie Kux, for industry entitled ‘‘Bioequivalence confidential information that you or a
Associate Commissioner for Policy. Recommendations for Specific third party may not wish to be posted,
[FR Doc. 2016–08689 Filed 4–14–16; 8:45 am] Products’’ that explained the process such as medical information, your or
BILLING CODE 4164–01–P
that would be used to make product- anyone else’s Social Security number, or
specific BE recommendations available confidential business information, such
to the public on FDA’s Web site. The BE as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND recommendations identified in this that if you include your name, contact
HUMAN SERVICES notice were developed using the process information, or other information that
described in that guidance. identifies you in the body of your
Food and Drug Administration DATES: Although you can comment on comments, that information will be
any guidance at any time (see 21 CFR posted on http://www.regulations.gov.
[Docket No. FDA–2007–D–0369]
10.115(g)(5)), to ensure that the Agency • If you want to submit a comment
Product-Specific Bioequivalence considers your comment on this draft with confidential information that you
Recommendations; Draft and Revised guidance before it begins work on the do not wish to be made available to the
Draft Guidances for Industry; final version of the guidance, submit public, submit the comment as a
Availability either electronic or written comments written/paper submission and in the
on the draft guidance by June 14, 2016. manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
HHS. as follows: Written/Paper Submissions
ACTION: Notice of availability.
Electronic Submissions Submit written/paper submissions as
SUMMARY: The Food and Drug Submit electronic comments in the follows:
Administration (FDA or Agency) is following way: • Mail/Hand delivery/Courier (for
announcing the availability of • Federal eRulemaking Portal: http:// written/paper submissions): Division of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
additional draft and revised draft www.regulations.gov. Follow the Dockets Management (HFA–305), Food
product-specific bioequivalence (BE) instructions for submitting comments. and Drug Administration, 5630 Fishers
recommendations. The Comments submitted electronically, Lane, Rm. 1061, Rockville, MD 20852.
recommendations provide product- including attachments, to http:// • For written/paper comments
specific guidance on the design of BE www.regulations.gov will be posted to submitted to the Division of Dockets
studies to support abbreviated new drug the docket unchanged. Because your Management, FDA will post your
applications (ANDAs). In the Federal comment will be made public, you are comment, as well as any attachments,
Register of June 11, 2010, FDA solely responsible for ensuring that your except for information submitted,
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Document Created: 2016-04-15 00:54:57
Document Modified: 2016-04-15 00:54:57
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 14, 2016. | |
| Contact | Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 4244, Silver Spring, MD 20993-0002, 301- 796-3191; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Pl., Rm.130, Rockville, MD 20855, 240-402-5623. | |
| FR Citation | 81 FR 22281 |
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