82 FR 3336 - Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 7 (January 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 7 (January 11, 2017)
| Page Range | 3336-3338 | |
| FR Document | 2017-00411 |
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)] [Notices] [Pages 3336-3338] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00411] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-0198] Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios. [[Page 3337]] DATES: Submit either electronic or written comments on this guidance at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-D-0198 for ``Current Good Manufacturing Practice Requirements for Combination Products; Final Guidance for Industry and FDA Staff.'' 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 guidance document entitled ``Current Good Manufacturing Practice Requirements for Combination Products'' to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Burns or John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301- 796-8930. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance provides background on combination products, including an overview of the document on CGMP requirements for combination products, which published in the Federal Register of January 22, 2013 (78 FR 4307), and the role of the lead center and other Agency components with respect to combination product CGMP issues. The guidance addresses general considerations for CGMP requirements for combination products and the purpose and content of specific CGMP provisions addressed in part 4 (21 CFR part 4). The guidance also contains hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in part 4 by presenting compliance considerations for specific types of combination products. FDA carefully considered the comments received on the draft guidance, and, where possible, has incorporated into the final guidance additional detailed discussion of how the requirements apply and acceptable CGMP compliance approaches. FDA encourages combination product manufacturers to contact the lead Center for their combination product and/or the Office of Combination Products if they have questions on CGMP compliance or approaches they are considering for meeting CGMP requirements. II. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf. III. Paperwork Reduction Act This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We note that the information collected under the underlying CGMP regulations for drugs, devices, and biological products, including current good tissue practices for human cells, tissues, and cellular and tissue-based products, found at parts 211, 820, 600 through 680, and 1271 (21 CFR parts [[Page 3338]] 211, 820, 600 through 680, and 1271), have already been approved and are in effect. The provisions of part 211 are approved under OMB control number 0910-0139. The provisions of part 820 are approved under OMB control number 0910-0073. The provisions of parts 606 and 640 are approved under OMB control number 0910-0116. The provisions of part 610 are approved under OMB control numbers 0910-0116 and 0910-0338 (also for part 680). The provisions of part 1271, subparts C and D, are approved under OMB control number 0910-0543. Dated: January 6, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00411 Filed 1-10-17; 8:45 am] BILLING CODE 4164-01-P
![3336 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
information that you do not wish to be I. Background The draft guidance, when finalized, will
made publicly available submit your FDA is announcing the availability of represent the current thinking of FDA
comments only as a written/paper a draft guidance for industry entitled on this topic. It does not establish any
submission. You should submit two ‘‘Recommended Statement for Over-the- rights for any person and is not binding
copies total. One copy will include the Counter Aspirin-Containing Drug on FDA or the public. You can use an
information you claim to be confidential Products Labeled With Cardiovascular alternative approach if it satisfies the
with a heading or cover note that states Related Imagery.’’ Aspirin is a common requirements of the applicable statutes
‘‘THIS DOCUMENT CONTAINS active ingredient in many prescription and regulations.
CONFIDENTIAL INFORMATION.’’ The and OTC drug products. Most OTC II. Paperwork Reduction Act of 1995
Agency will review this copy, including aspirin drug products are currently
the claimed confidential information, in The recommendations in this draft
marketed pursuant to the Tentative
its consideration of comments. The guidance are not subject to review by
Final Monograph (TFM) for Internal
second copy, which will have the the Office of Management and Budget
Analgesic, Antipyretic, and
claimed confidential information because they do not constitute a
Antirheumatic (IAAA) Drug Products
redacted/blacked out, will be available ‘‘collection of information’’ under the
(53 FR 46204, November 16, 1988) for
for public viewing and posted on http:// Paperwork Reduction Act of 1995 (44
the temporary relief of minor aches and
www.regulations.gov. Submit both U.S.C. 3501–3520). Rather, the labeling
pains associated with a cold, headache,
copies to the Division of Dockets statements are a ‘‘public disclosure of
backache, toothache, premenstrual and
Management. If you do not wish your information originally supplied by the
menstrual cramps; minor pain of
name and contact information to be Federal government to the recipient for
arthritis; and reduction in fever.
made publicly available, you can In addition to the OTC conditions of the purpose of disclosure to the public’’
provide this information on the cover use in the IAAA TFM, FDA regulations (5 CFR 1320.3(c)(2)).
sheet and not in the body of your at § 343.80 (21 CFR 343.80) also contain III. Electronic Access
comments and you must identify this professional labeling about
information as ‘‘confidential.’’ Any Persons with access to the Internet
cardiovascular uses of aspirin directed
may obtain the draft guidance at either
information marked as ‘‘confidential’’ at health care practitioners (63 FR
http://www.fda.gov/Drugs/Guidance
will not be disclosed except in 56802, October 23, 1998). After
ComplianceRegulatoryInformation/
accordance with 21 CFR 10.20 and other publication of the professional labeling
Guidances/default.htm or http://
applicable disclosure law. For more regulation for aspirin, some OTC aspirin
www.regulations.gov.
information about FDA’s posting of labels were modified to include
comments to public dockets, see 80 FR cardiovascular related imagery (e.g., Dated: January 5, 2017.
56469, September 18, 2015, or access heart image, electrocardiography Leslie Kux,
the information at: http://www.fda.gov/ graphic, stethoscope around a heart Associate Commissioner for Policy.
regulatoryinformation/dockets/ image). However, the final rule for [FR Doc. 2017–00374 Filed 1–10–17; 8:45 am]
default.htm. IAAA products at § 343.80 authorizes BILLING CODE 4164–01–P
Docket: For access to the docket to labeling for cardiovascular events only
read background documents or the in professional labeling directed to
electronic and written/paper comments health care professionals. DEPARTMENT OF HEALTH AND
received, go to http:// Because of the potential side effects HUMAN SERVICES
www.regulations.gov and insert the associated with long-term aspirin
therapy, FDA recommends that any Food and Drug Administration
docket number, found in brackets in the
cardiovascular related imagery on OTC
heading of this document, into the [Docket No. FDA–2015–D–0198]
aspirin labels be accompanied by a
‘‘Search’’ box and follow the prompts
statement that reminds consumers to Current Good Manufacturing Practice
and/or go to the Division of Dockets
talk to their health care provider before Requirements for Combination
Management, 5630 Fishers Lane, Rm.
using aspirin for the professional Products; Guidance for Industry and
1061, Rockville, MD 20852.
indication of secondary prevention of Food and Drug Administration Staff;
Submit written requests for single cardiovascular events. Therefore, this
copies of the draft guidance to the Availability
draft guidance provides that FDA does
Division of Drug Information, Center for not intend to take action against AGENCY: Food and Drug Administration,
Drug Evaluation and Research, Food manufacturers of single-ingredient HHS.
and Drug Administration, 10001 New aspirin, buffered aspirin, and aspirin in ACTION: Notice of availability.
Hampshire Ave., Hillandale Building, combination with an antacid, marketed
4th Floor, Silver Spring, MD 20993– pursuant to the TFM for IAAA Drug SUMMARY: The Food and Drug
0002. Send one self-addressed adhesive Products because the product label Administration (FDA) is announcing the
label to assist that office in processing includes cardiovascular related imagery availability of a final guidance for
your request. See the SUPPLEMENTARY (e.g., heart image, electrocardiography industry and FDA staff entitled ‘‘Current
INFORMATION section for electronic graphic, stethoscope around a heart Good Manufacturing Practice
access to the draft guidance document. image) if the label also includes Requirements for Combination
language as described in the draft Products.’’ The guidance describes and
FOR FURTHER INFORMATION CONTACT:
explains the document on current good
sradovich on DSK3GMQ082PROD with NOTICES
Emily Baker, Center for Drug Evaluation guidance recommending that patients
talk to a health care professional before manufacturing practice (CGMP)
and Research, Food and Drug
taking aspirin for cardiovascular uses requirements for combination products,
Administration, 10903 New Hampshire
and the product is otherwise marketed which published in the Federal Register
Ave., Bldg. 51, Rm. 5203, Silver Spring,
in accordance with the TFM. of January 22, 2013, and includes
MD 20993–0002, 301–796–7524,
This draft guidance is being issued general considerations for CGMP
Emily.Baker@fda.hhs.gov.
consistent with FDA’s good guidance compliance as well as analysis of
SUPPLEMENTARY INFORMATION: practices regulation (21 CFR 10.115). hypothetical scenarios.
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![3338 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
211, 820, 600 through 680, and 1271), the data collection plans and draft now Table 2 due to the elimination of
have already been approved and are in instruments, email paperwork@hrsa.gov Table 2B. There are no other changes to
effect. The provisions of part 211 are or call the HRSA Information Collection this form.
approved under OMB control number Clearance Officer at (301) 443–1984. • Table 2B—NAT: Graduates
0910–0139. The provisions of part 820 SUPPLEMENTARY INFORMATION: When Supported by Traineeship Data—Rural,
are approved under OMB control submitting comments or requesting Underserved, or Public Health (7/01/15–
number 0910–0073. The provisions of information, please include the 6/30/16) will be discontinued.
parts 606 and 640 are approved under information request collection title for Rationale: The NAT Program Specific
OMB control number 0910–0116. The reference. Data Forms will be revised to streamline
provisions of part 610 are approved Information Collection Request Title: the process and capture only essential
under OMB control numbers 0910–0116 Nurse Anesthetist Traineeship (NAT) data for use in the formula calculation,
and 0910–0338 (also for part 680). The Program Application ensure grantee compliance, and measure
provisions of part 1271, subparts C and OMB No.: 0915–0374—Revision and evaluate the program.
D, are approved under OMB control Abstract: HRSA provides advanced
number 0910–0543. education nursing training grants to Likely Respondents: Eligible
educational institutions to increase the applicants are education programs that
Dated: January 6, 2017. provide registered nurses with full-time
Leslie Kux, numbers of Nurse Anesthetists through
the NAT Program. The NAT Program is nurse anesthesia education and are
Associate Commissioner for Policy. accredited by the Council on
authorized by Section 811 of the Public
[FR Doc. 2017–00411 Filed 1–10–17; 8:45 am]
Health Service (PHS) Act (42 U.S.C. Accreditation (COA) of Nurse
BILLING CODE 4164–01–P
296j). The NAT Tables request Anesthesia Educational Programs. Such
information on program participants programs may include schools of
from the previous year, including the nursing, nursing centers, academic
DEPARTMENT OF HEALTH AND health centers, state or local
HUMAN SERVICES number of enrollees; number of
enrollees/trainees supported; number of governments, and other public or
graduates; number of graduates private nonprofit entities authorized by
Health Resources and Services the Secretary to confer degrees to
Administration supported; projected data on the
number of enrollees/trainees and registered nurses for full-time nurse
Agency Information Collection graduates; the degree program (Master’s anesthesia education. Faith-based and
Activities: Proposed Collection: Public and Doctoral) the Nurse Anesthesia community-based organizations, Tribes,
Comment Request; Nurse Anesthetist student trainees are enrolling into and/ and tribal organizations may apply for
Traineeship (NAT) Program or from which enrollees/trainees are these funds if otherwise eligible. In
graduating; and the distribution of addition to the 50 states, the District of
AGENCY: Health Resources and Services Columbia, Guam, the Commonwealth of
Nurse Anesthetists who practice in
Administration (HRSA), Department of Puerto Rico, the Northern Mariana
underserved, rural, and/or public health
Health and Human Services. Islands, American Samoa, the U.S.
practice settings.
ACTION: Notice. Need and Proposed Use of the Virgin Islands, the Federated States of
Information: Funds appropriated for the Micronesia, the Republic of the
SUMMARY: In compliance with the Marshall Islands, and the Republic of
requirement for opportunity for public NAT Program are distributed among
eligible institutions based on a formula, Palau may apply.
comment on proposed data collection
projects of the Paperwork Reduction Act as permitted by PHS Act Section Burden Statement: Burden in this
of 1995, HRSA announces plans to 806(e)(1). HRSA uses the data from the context means the time expended by
submit an Information Collection NAT Tables to determine the award persons to generate, maintain, retain,
Request (ICR), described below, to the amount, ensure compliance with disclose or provide the information
Office of Management and Budget programmatic and grant requirements, requested. This includes the time
(OMB). Prior to submitting the ICR to and provide information to the public needed to review instructions; to
OMB, HRSA seeks comments from the and Congress. develop, acquire, install and utilize
public regarding the burden estimate, HRSA is streamlining the data technology and systems for the purpose
below, or any other aspect of the ICR. collection forms from three tables to two of collecting, validating and verifying
tables by making the following changes: information, processing and
DATES: Comments on this ICR should be
• Table 1—NAT: Enrollment, maintaining information, and disclosing
received no later than February 10, and providing information; to train
Traineeship Support, Graduates,
2017. personnel and to be able to respond to
Graduates Supported, and Projected
ADDRESSES: Submit your comments to Data will no longer capture data by a collection of information; to search
paperwork@hrsa.gov or mail the HRSA students in the first 12 months of study data sources; to complete and review
Information Collection Clearance and students beyond the first 12 months the collection of information; and to
Officer, Room 14N39, 5600 Fishers of study in the program. Data will transmit or otherwise disclose the
Lane, Rockville, MD 20857. continue to be captured by Master’s and information. The total annual burden
FOR FURTHER INFORMATION CONTACT: To Doctoral students. hours estimated for this Information
request more information on the • Table 2A—NAT: Graduate Data— Collection Request are summarized in
proposed project or to obtain a copy of Rural, Underserved, or Public Health is the table below.
sradovich on DSK3GMQ082PROD with NOTICES
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Document Created: 2018-02-01 14:59:32
Document Modified: 2018-02-01 14:59:32
| 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 this guidance at any time. | |
| Contact | Melissa Burns or John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301- 796-8930. | |
| FR Citation | 82 FR 3336 |
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