Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability, 22174-22175 [2016-08684]

Download as PDF jstallworth on DSK7TPTVN1PROD with RULES 22174 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Rules and Regulations paragraphs (b)(2)(i) through (v) of this section and has a supplementary leverage ratio of 3.0 percent or greater, as calculated in accordance with § 324.11 of subpart B of this part. (3) ‘‘Undercapitalized’’ if it: (i) Has a total risk-based capital ratio that is less than 8.0 percent; or (ii) Has a Tier 1 risk-based capital ratio that is less than 6.0 percent; or (iii) Has a common equity tier 1 capital ratio that is less than 4.5 percent; or (iv) Has a leverage ratio that is less than 4.0 percent. (v) Beginning January 1, 2018, an advanced approaches FDIC-supervised institution will be deemed to be ‘‘undercapitalized’’ if it has a supplementary leverage ratio of less than 3.0 percent, as calculated in accordance with § 324.11. (4) ‘‘Significantly undercapitalized’’ if it has: (i) A total risk-based capital ratio that is less than 6.0 percent; or (ii) A Tier 1 risk-based capital ratio that is less than 4.0 percent; or (iii) A common equity tier 1 capital ratio that is less than 3.0 percent; or (iv) A leverage ratio that is less than 3.0 percent. (5) ‘‘Critically undercapitalized’’ if the insured depository institution has a ratio of tangible equity to total assets that is equal to or less than 2.0 percent. (c) Capital categories for insured branches of foreign banks. For purposes of the provisions of section 38 of the FDI Act and this subpart H, an insured branch of a foreign bank shall be deemed to be: (1) ‘‘Well capitalized’’ if the insured branch: (i) Maintains the pledge of assets required under § 347.209 of this chapter; and (ii) Maintains the eligible assets prescribed under § 347.210 of this chapter at 108 percent or more of the preceding quarter’s average book value of the insured branch’s third-party liabilities; and (iii) Has not received written notification from: (A) The OCC to increase its capital equivalency deposit pursuant to 12 CFR 28.15, or to comply with asset maintenance requirements pursuant to 12 CFR 28.20; or (B) The FDIC to pledge additional assets pursuant to § 347.209 of this chapter or to maintain a higher ratio of eligible assets pursuant to § 347.210 of this chapter. (2) ‘‘Adequately capitalized’’ if the insured branch: (i) Maintains the pledge of assets required under § 347.209 of this chapter; and VerDate Sep<11>2014 14:40 Apr 14, 2016 Jkt 238001 (ii) Maintains the eligible assets prescribed under § 347.210 of this chapter at 106 percent or more of the preceding quarter’s average book value of the insured branch’s third-party liabilities; and (iii) Does not meet the definition of a well capitalized insured branch. (3) ‘‘Undercapitalized’’ if the insured branch: (i) Fails to maintain the pledge of assets required under § 347.209 of this chapter; or (ii) Fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 106 percent or more of the preceding quarter’s average book value of the insured branch’s third-party liabilities. (4) ‘‘Significantly undercapitalized’’ if it fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 104 percent or more of the preceding quarter’s average book value of the insured branch’s third-party liabilities. (5) ‘‘Critically undercapitalized’’ if it fails to maintain the eligible assets prescribed under § 347.210 of this chapter at 102 percent or more of the preceding quarter’s average book value of the insured branch’s third-party liabilities. (d) Reclassifications based on supervisory criteria other than capital. The FDIC may reclassify a well capitalized FDIC-supervised institution as adequately capitalized and may require an adequately capitalized FDICsupervised institution or an undercapitalized FDIC-supervised institution to comply with certain mandatory or discretionary supervisory actions as if the FDIC-supervised institution were in the next lower capital category (except that the FDIC may not reclassify a significantly undercapitalized FDIC-supervised institution as critically undercapitalized) (each of these actions are hereinafter referred to generally as ‘‘reclassifications’’) in the following circumstances: (1) Unsafe or unsound condition. The FDIC has determined, after notice and opportunity for hearing pursuant to § 308.202(a) of this chapter, that the FDIC-supervised institution is in unsafe or unsound condition; or (2) Unsafe or unsound practice. The FDIC has determined, after notice and opportunity for hearing pursuant to § 308.202(a) of this chapter, that, in the most recent examination of the FDICsupervised institution, the FDICsupervised institution received and has not corrected a less-than-satisfactory rating for any of the categories of asset PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 quality, management, earnings, or liquidity. Dated at Washington, DC, this 12th day of April, 2016. By order of the Board of Directors. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. 2016–08717 Filed 4–14–16; 8:45 am] BILLING CODE 6714–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 106 [Docket No. FDA–2014–D–0044] Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ‘‘Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.’’ The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas. 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 E:\FR\FM\15APR1.SGM 15APR1 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Rules and Regulations jstallworth on DSK7TPTVN1PROD with RULES 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– 2014–D–0044 for the ‘‘Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.’’ 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 VerDate Sep<11>2014 14:40 Apr 14, 2016 Jkt 238001 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 to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS–850), Food and Drug Administration, 5100 Paint Branch Pkwy., 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 guidance. FOR FURTHER INFORMATION CONTACT: Carrie L. Assar, Center for Food Safety and Applied Nutrition (HFS–850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1453. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ‘‘Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.’’ Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of sections 412(a), (b), and (c) of the FD&C Act. These formulas are customarily referred to as ‘‘exempt infant formulas.’’ The guidance is intended to describe the significance of the regulations in 21 CFR part 106 for the production of exempt infant PO 00000 Frm 00003 Fmt 4700 Sfmt 9990 22175 formulas. A final rule amending part 106 was published in the Federal Register on June 10, 2014 (79 FR 33057). In the Federal Register of February 10, 2014 (79 FR 7610), we made available a draft guidance entitled ‘‘Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports’’ and gave interested parties an opportunity to submit comments by May 12, 2014, for us to consider before beginning work on the final version of the guidance. We received one comment on the draft guidance, but the comment pertained to infant formula ingredients and not to the guidance itself. Consequently, we did not modify the guidance in response to the comment. However, we have modified the final guidance where appropriate to refer to the final rule that was published in the Federal Register on June 10, 2014. The guidance announced in this notice finalizes the draft guidance dated February 2014. We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance 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 contains information collection provisions that 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 106 have been approved under OMB control number 0910–0811. III. Electronic Access Persons with access to the Internet may obtain the guidance at 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: April 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08684 Filed 4–14–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\15APR1.SGM 15APR1

Agencies

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Rules and Regulations]
[Pages 22174-22175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 106

[Docket No. FDA-2014-D-0044]


Exempt Infant Formula Production: Current Good Manufacturing 
Practices, Quality Control Procedures, Conduct of Audits, and Records 
and Reports; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Exempt Infant 
Formula Production: Current Good Manufacturing Practices (CGMPs), 
Quality Control Procedures, Conduct of Audits, and Records and 
Reports.'' The guidance describes our current thinking on the 
manufacturing of exempt infant formula in relation to the requirements 
for CGMPs, quality control procedures, conduct of audits, and records 
and reports that apply to non-exempt infant formulas.

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

[[Page 22175]]

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-2014-D-0044 for the ``Exempt Infant Formula Production: Current 
Good Manufacturing Practices (CGMPs), Quality Control Procedures, 
Conduct of Audits, and Records and Reports.'' 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 to the 
Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint 
Branch Pkwy., 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 
guidance.

FOR FURTHER INFORMATION CONTACT: Carrie L. Assar, Center for Food 
Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1453.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Exempt Infant Formula Production: Current Good Manufacturing 
Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and 
Records and Reports.'' Section 412(h)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant 
formula that is represented and labeled for use by an infant with an 
inborn error of metabolism, low birth weight, or who otherwise has an 
unusual medical or dietary problem from the requirements of sections 
412(a), (b), and (c) of the FD&C Act. These formulas are customarily 
referred to as ``exempt infant formulas.'' The guidance is intended to 
describe the significance of the regulations in 21 CFR part 106 for the 
production of exempt infant formulas. A final rule amending part 106 
was published in the Federal Register on June 10, 2014 (79 FR 33057).
    In the Federal Register of February 10, 2014 (79 FR 7610), we made 
available a draft guidance entitled ``Draft Guidance for Industry; 
Exempt Infant Formula Production: Current Good Manufacturing Practices 
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records and 
Reports'' and gave interested parties an opportunity to submit comments 
by May 12, 2014, for us to consider before beginning work on the final 
version of the guidance. We received one comment on the draft guidance, 
but the comment pertained to infant formula ingredients and not to the 
guidance itself. Consequently, we did not modify the guidance in 
response to the comment. However, we have modified the final guidance 
where appropriate to refer to the final rule that was published in the 
Federal Register on June 10, 2014. The guidance announced in this 
notice finalizes the draft guidance dated February 2014.
    We are issuing this guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The guidance 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 contains information collection provisions that 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 106 have been approved under 
OMB control number 0910-0811.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
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: April 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08684 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P