81 FR 75692 - What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 211 (November 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 211 (November 1, 2016)
| Page Range | 75692-75693 | |
| FR Document | 2016-26315 |
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)] [Rules and Regulations] [Pages 75692-75693] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26315] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2011-N-0920] What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food''--Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' DATES: Submit either electronic or written comments on FDA guidances 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-2011-N-0920 for ``What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR part 117).'' 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 [[Page 75693]] 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 SECG to the Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1700. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 17, 2015 (80 FR 55908), we issued a final rule titled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' (the final rule) in which we modernized the longstanding current good manufacturing practice requirements in 21 CFR part 110 and added the requirements for facilities subject to registration to establish and implement hazard analysis and risk-based preventive controls for human food. The final rule, which is codified at part 117 (21 CFR part 117), became effective November 16, 2015 (except for the amendment to part 110 in instruction 13, which is effective September 17, 2018, and paragraph (2) of the definition of ``qualified auditor'' in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2), and 117.475(c)(13)) but has compliance dates staggered over several years after publication of the final rule. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104- 121, as amended by Pub. L. 110-28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the current thinking of FDA on this topic. 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. Paperwork Reduction Act of 1995 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). The collections of information in 21 CFR part 117 have been approved under OMB control number 0910-0751. III. Electronic Access Persons with access to the Internet may obtain the SECG at either http://www.fda.gov/FoodGuidances, or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26315 Filed 10-31-16; 8:45 am] BILLING CODE 4164-01-P
![75692 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations
Applied Nutrition, 21 CFR parts 73 and Dated: October 25, 2016. as a manufacturing process. Please note
74 are amended as follows: Susan Bernard, that if you include your name, contact
Director, Office of Regulations, Policy and information, or other information that
PART 73—LISTING OF COLOR Social Science, Center for Food Safety and identifies you in the body of your
ADDITIVES EXEMPT FROM Applied Nutrition. comments, that information will be
CERTIFICATION [FR Doc. 2016–26310 Filed 10–31–16; 8:45 am] posted on http://www.regulations.gov.
BILLING CODE 4164–01–P • If you want to submit a comment
■ 1. The authority citation for part 73 with confidential information that you
continues to read as follows: do not wish to be made available to the
Authority: 21 U.S.C. 321, 341, 342, 343, DEPARTMENT OF HEALTH AND public, submit the comment as a
348, 351, 352, 355, 361, 362, 371, 379e. HUMAN SERVICES written/paper submission and in the
manner detailed (see ‘‘Written/Paper
■ 2. In § 73.3126, revise paragraph (b)(1) Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
to read as follows:
21 CFR Part 117 Written/Paper Submissions
§ 73.3126 Titanium dioxide.
Submit written/paper submissions as
* * * * * [Docket No. FDA–2011–N–0920]
follows:
(b) * * * (1) The substance listed in
What You Need To Know About the • Mail/Hand delivery/Courier (for
paragraph (a) of this section may be written/paper submissions): Division of
Food and Drug Administration
used as a color additive in contact Dockets Management (HFA–305), Food
Regulation: Current Good
lenses and intraocular lens orientation and Drug Administration, 5630 Fishers
Manufacturing Practice, Hazard
marks in amounts not to exceed the Lane, Rm. 1061, Rockville, MD 20852.
Analysis, and Risk-Based Preventive
minimum reasonably required to • For written/paper comments
Controls for Human Food; Small Entity
accomplish the intended coloring effect. submitted to the Division of Dockets
Compliance Guide; Availability Management, FDA will post your
* * * * *
AGENCY: Food and Drug Administration, comment, as well as any attachments,
PART 74—LISTING OF COLOR HHS. except for information submitted,
ADDITIVES SUBJECT TO ACTION: Notification of availability. marked and identified, as confidential,
CERTIFICATION if submitted as detailed in
SUMMARY: The Food and Drug ‘‘Instructions.’’
■ 3. The authority citation for part 74 Administration (FDA, the Agency, or Instructions: All submissions received
continues to read as follows: we) is announcing the availability of a must include the Docket No. FDA–
Authority: 21 U.S.C. 321, 341, 342, 343,
guidance for industry entitled ‘‘What 2011–N–0920 for ‘‘What You Need To
348, 351, 352, 355, 361, 362, 371, 379e. You Need To Know About the FDA Know About the FDA Regulation:
Regulation: Current Good Current Good Manufacturing Practice,
■ 4. In § 74.3045, revise paragraphs Manufacturing Practice, Hazard Hazard Analysis, and Risk-Based
(c)(1) introductory text and (c)(1)(i) to Analysis, and Risk-Based Preventive Preventive Controls for Human Food (21
read as follows: Controls for Human Food’’—Small CFR part 117).’’ Received comments
§ 74.3045 [Phthalocyaninato (2-)] copper.
Entity Compliance Guide. The small will be placed in the docket and, except
entity compliance guide (SECG) is for those submitted as ‘‘Confidential
* * * * * intended to help small entities comply Submissions,’’ publicly viewable at
(c) * * * (1) The color additive with the final rule titled ‘‘Current Good http://www.regulations.gov or at the
[phthalocyaninato(2-)] copper may be Manufacturing Practice, Hazard Division of Dockets Management
safely used to color polypropylene Analysis, and Risk-Based Preventive between 9 a.m. and 4 p.m., Monday
sutures, polybutester (the generic Controls for Human Food.’’ through Friday.
designation for the suture fabricated DATES: Submit either electronic or • Confidential Submissions—To
from 1,4-benzenedicarboxylic acid, written comments on FDA guidances at submit a comment with confidential
polymer with 1,4-butanediol and alpha- any time. information that you do not wish to be
hydro-omega-hydroxypoly(oxy-1,4- made publicly available, submit your
ADDRESSES: You may submit comments
butanediyl), CAS Reg. No. 37282–12–5) comments only as a written/paper
as follows:
nonabsorbable sutures for use in general submission. You should submit two
and ophthalmic surgery, polybutylene Electronic Submissions copies total. One copy will include the
terephthalate nonabsorbable Submit electronic comments in the information you claim to be confidential
monofilament sutures for general and following way: with a heading or cover note that states
ophthalmic surgery, nonabsorbable • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
sutures made from poly(vinylidene www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
fluoride) and poly(vinylidene fluoride- instructions for submitting comments. Agency will review this copy, including
co-hexafluoropropylene) for general and Comments submitted electronically, the claimed confidential information, in
ophthalmic surgery, including attachments, to http:// its consideration of comments. The
polymethylmethacrylate monofilament www.regulations.gov will be posted to second copy, which will have the
used as supporting haptics for the docket unchanged. Because your claimed confidential information
intraocular lenses, and polymers used in comment will be made public, you are redacted/blacked out, will be available
jstallworth on DSK7TPTVN1PROD with RULES
orientation marks for intraocular lenses, solely responsible for ensuring that your for public viewing and posted on http://
subject to the following restrictions: comment does not include any www.regulations.gov. Submit both
(i) The quantity of the color additive confidential information that you or a copies to the Division of Dockets
does not exceed 0.5 percent by weight third party may not wish to be posted, Management. If you do not wish your
of the suture, haptic material, or such as medical information, your or name and contact information to be
orientation mark. anyone else’s Social Security number, or made publicly available, you can
* * * * * confidential business information, such provide this information on the cover
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![Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations 75693
sheet and not in the body of your dates staggered over several years after DEPARTMENT OF HEALTH AND
comments and you must identify this publication of the final rule. HUMAN SERVICES
information as ‘‘confidential.’’ Any We examined the economic
information marked as ‘‘confidential’’ Food and Drug Administration
implications of the final rule as required
will not be disclosed except in by the Regulatory Flexibility Act (5
accordance with 21 CFR 10.20 and other 21 CFR Part 507
U.S.C. 601–612) and determined that
applicable disclosure law. For more [Docket No. FDA–2011–N–0922]
the final rule will have a significant
information about FDA’s posting of
comments to public dockets, see 80 FR economic impact on a substantial
What You Need To Know About the
56469, September 18, 2015, or access number of small entities. In compliance
Food and Drug Administration
the information at: http://www.fda.gov/ with section 212 of the Small Business Regulation: Current Good
regulatoryinformation/dockets/ Regulatory Enforcement Fairness Act Manufacturing Practice, Hazard
default.htm. (Pub. L. 104–121, as amended by Pub. Analysis, and Risk-Based Preventive
Docket: For access to the docket to L. 110–28), we are making available the Controls for Food for Animals; Small
read background documents or the SECG to explain the actions that a small Entity Compliance Guide; Availability
electronic and written/paper comments entity must take to comply with the
rule. AGENCY: Food and Drug Administration,
received, go to http:// HHS.
www.regulations.gov and insert the We are issuing the SECG consistent
ACTION: Notification of availability.
docket number, found in brackets in the with our good guidance practices
heading of this document, into the regulation (21 CFR 10.115(c)(2)). The SUMMARY: The Food and Drug
‘‘Search’’ box and follow the prompts SECG represents the current thinking of Administration (FDA, the Agency, or
and/or go to the Division of Dockets FDA on this topic. It does not establish we) is announcing the availability of a
Management, 5630 Fishers Lane, Rm. any rights for any person and is not guidance for industry #241 entitled
1061, Rockville, MD 20852. binding on FDA or the public. You can ‘‘What You Need To Know About the
Submit written requests for single use an alternative approach if it satisfies FDA Regulation: Current Good
copies of the SECG to the Office of Food the requirements of the applicable Manufacturing Practice, Hazard
Safety, Center for Food Safety and statutes and regulations. Analysis, and Risk-Based Preventive
Applied Nutrition, Food and Drug Controls for Food for Animals’’—Small
Administration, 5001 Campus Dr., II. Paperwork Reduction Act of 1995 Entity Compliance Guide. The small
College Park, MD 20740. Send two self- entity compliance guide (SECG) is
This guidance refers to previously
addressed adhesive labels to assist that intended to help small entities comply
approved collections of information with the final rule titled ‘‘Current Good
office in processing your request. See
the SUPPLEMENTARY INFORMATION section found in FDA regulations. These Manufacturing Practice, Hazard
for electronic access to the SECG. collections of information are subject to Analysis, and Risk-Based Preventive
review by the Office of Management and Controls for Food for Animals.’’
FOR FURTHER INFORMATION CONTACT: Budget (OMB) under the Paperwork
Jenny Scott, Center for Food Safety and DATES: Submit either electronic or
Reduction Act of 1995 (44 U.S.C. 3501– written comments on FDA guidances at
Applied Nutrition, Food and Drug 3520). The collections of information in
Administration, 5001 Campus Dr., any time.
21 CFR part 117 have been approved ADDRESSES: You may submit comments
College Park, MD 20740, 240–402–1700.
under OMB control number 0910–0751. as follows:
SUPPLEMENTARY INFORMATION:
III. Electronic Access Electronic Submissions
I. Background
Persons with access to the Internet Submit electronic comments in the
In the Federal Register of September may obtain the SECG at either http:// following way:
17, 2015 (80 FR 55908), we issued a www.fda.gov/FoodGuidances, or http:// • Federal eRulemaking Portal: http://
final rule titled ‘‘Current Good www.regulations.gov. Use the FDA Web www.regulations.gov. Follow the
Manufacturing Practice, Hazard instructions for submitting comments.
site listed in the previous sentence to
Analysis, and Risk-Based Preventive Comments submitted electronically,
find the most current version of the
Controls for Human Food’’ (the final including attachments, to http://
rule) in which we modernized the guidance.
www.regulations.gov will be posted to
longstanding current good Dated: October 26, 2016. the docket unchanged. Because your
manufacturing practice requirements in Leslie Kux, comment will be made public, you are
21 CFR part 110 and added the Associate Commissioner for Policy. solely responsible for ensuring that your
requirements for facilities subject to [FR Doc. 2016–26315 Filed 10–31–16; 8:45 am] comment does not include any
registration to establish and implement confidential information that you or a
BILLING CODE 4164–01–P
hazard analysis and risk-based third party may not wish to be posted,
preventive controls for human food. The such as medical information, your or
final rule, which is codified at part 117 anyone else’s Social Security number, or
(21 CFR part 117), became effective confidential business information, such
November 16, 2015 (except for the as a manufacturing process. Please note
amendment to part 110 in instruction that if you include your name, contact
jstallworth on DSK7TPTVN1PROD with RULES
13, which is effective September 17, information, or other information that
2018, and paragraph (2) of the definition identifies you in the body of your
of ‘‘qualified auditor’’ in § 117.3, and comments, that information will be
§§ 117.5(k)(2), 117.8, 117.405(a)(2), posted on http://www.regulations.gov.
117.405(c), 117.410(d)(2)(ii), 117.430(d), • If you want to submit a comment
117.435(d), 117.475(c)(2), and with confidential information that you
117.475(c)(13)) but has compliance do not wish to be made available to the
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Document Created: 2016-11-01 02:35:38
Document Modified: 2016-11-01 02:35:38
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Jenny Scott, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1700. | |
| FR Citation | 81 FR 75692 |
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