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, 75692-75693 [2016-26315]

Download as PDF 75692 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations Applied Nutrition, 21 CFR parts 73 and 74 are amended as follows: PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Dated: October 25, 2016. Susan Bernard, Director, Office of Regulations, Policy and Social Science, Center for Food Safety and Applied Nutrition. [FR Doc. 2016–26310 Filed 10–31–16; 8:45 am] BILLING CODE 4164–01–P 1. The authority citation for part 73 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. DEPARTMENT OF HEALTH AND HUMAN SERVICES 2. In § 73.3126, revise paragraph (b)(1) to read as follows: Food and Drug Administration ■ § 73.3126 21 CFR Part 117 Titanium dioxide. * * * * (b) * * * (1) The substance listed in paragraph (a) of this section may be used as a color additive in contact lenses and intraocular lens orientation marks in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. * * * * * [Docket No. FDA–2011–N–0920] PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION HHS. * Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. 4. In § 74.3045, revise paragraphs (c)(1) introductory text and (c)(1)(i) to read as follows: ■ [Phthalocyaninato (2-)] copper. jstallworth on DSK7TPTVN1PROD with RULES * * * * (c) * * * (1) The color additive [phthalocyaninato(2-)] copper may be safely used to color polypropylene sutures, polybutester (the generic designation for the suture fabricated from 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol and alphahydro-omega-hydroxypoly(oxy-1,4butanediyl), CAS Reg. No. 37282–12–5) nonabsorbable sutures for use in general and ophthalmic surgery, polybutylene terephthalate nonabsorbable monofilament sutures for general and ophthalmic surgery, nonabsorbable sutures made from poly(vinylidene fluoride) and poly(vinylidene fluorideco-hexafluoropropylene) for general and ophthalmic surgery, polymethylmethacrylate monofilament used as supporting haptics for intraocular lenses, and polymers used in orientation marks for intraocular lenses, subject to the following restrictions: (i) The quantity of the color additive does not exceed 0.5 percent by weight of the suture, haptic material, or orientation mark. * * * * * VerDate Sep<11>2014 15:21 Oct 31, 2016 Jkt 241001 Food and Drug Administration, Notification of availability. 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: SUMMARY: 3. The authority citation for part 74 continues to read as follows: * AGENCY: ACTION: ■ § 74.3045 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 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 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 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 E:\FR\FM\01NOR1.SGM 01NOR1 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Rules and Regulations 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 selfaddressed 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: jstallworth on DSK7TPTVN1PROD with RULES 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 § 117.3, and §§ 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 15:21 Oct 31, 2016 Jkt 241001 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 I. Background VerDate Sep<11>2014 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. 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 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 75693 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 507 [Docket No. FDA–2011–N–0922] What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry #241 entitled ‘‘What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’—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 Food for Animals.’’ DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: SUMMARY: 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 E:\FR\FM\01NOR1.SGM 01NOR1

Agencies

[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Rules and Regulations]
[Pages 75692-75693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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