81 FR 22174 - Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; 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 | 22174-22175 | |
| FR Document | 2016-08684 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Rules and Regulations] [Pages 22174-22175] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08684] ======================================================================= ----------------------------------------------------------------------- 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
![22174 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Rules and Regulations
paragraphs (b)(2)(i) through (v) of this (ii) Maintains the eligible assets quality, management, earnings, or
section and has a supplementary prescribed under § 347.210 of this liquidity.
leverage ratio of 3.0 percent or greater, chapter at 106 percent or more of the Dated at Washington, DC, this 12th day of
as calculated in accordance with preceding quarter’s average book value April, 2016.
§ 324.11 of subpart B of this part. of the insured branch’s third-party By order of the Board of Directors.
(3) ‘‘Undercapitalized’’ if it: liabilities; and
(i) Has a total risk-based capital ratio Federal Deposit Insurance Corporation.
(iii) Does not meet the definition of a
that is less than 8.0 percent; or Robert E. Feldman,
well capitalized insured branch.
(ii) Has a Tier 1 risk-based capital Executive Secretary.
(3) ‘‘Undercapitalized’’ if the insured
ratio that is less than 6.0 percent; or branch: [FR Doc. 2016–08717 Filed 4–14–16; 8:45 am]
(iii) Has a common equity tier 1 BILLING CODE 6714–01–P
(i) Fails to maintain the pledge of
capital ratio that is less than 4.5 percent;
assets required under § 347.209 of this
or
(iv) Has a leverage ratio that is less chapter; or
(ii) Fails to maintain the eligible DEPARTMENT OF HEALTH AND
than 4.0 percent. HUMAN SERVICES
(v) Beginning January 1, 2018, an assets prescribed under § 347.210 of this
advanced approaches FDIC-supervised chapter at 106 percent or more of the
preceding quarter’s average book value Food and Drug Administration
institution will be deemed to be
‘‘undercapitalized’’ if it has a of the insured branch’s third-party
liabilities. 21 CFR Part 106
supplementary leverage ratio of less
than 3.0 percent, as calculated in (4) ‘‘Significantly undercapitalized’’ if [Docket No. FDA–2014–D–0044]
accordance with § 324.11. it fails to maintain the eligible assets
(4) ‘‘Significantly undercapitalized’’ if prescribed under § 347.210 of this Exempt Infant Formula Production:
it has: chapter at 104 percent or more of the Current Good Manufacturing Practices,
(i) A total risk-based capital ratio that preceding quarter’s average book value Quality Control Procedures, Conduct
is less than 6.0 percent; or of the insured branch’s third-party of Audits, and Records and Reports;
(ii) A Tier 1 risk-based capital ratio liabilities. Guidance for Industry; Availability
that is less than 4.0 percent; or (5) ‘‘Critically undercapitalized’’ if it AGENCY: Food and Drug Administration,
(iii) A common equity tier 1 capital fails to maintain the eligible assets HHS.
ratio that is less than 3.0 percent; or prescribed under § 347.210 of this
(iv) A leverage ratio that is less than ACTION: Notification of availability.
chapter at 102 percent or more of the
3.0 percent. preceding quarter’s average book value SUMMARY: The Food and Drug
(5) ‘‘Critically undercapitalized’’ if the of the insured branch’s third-party Administration (FDA or we) is
insured depository institution has a liabilities. announcing the availability of a
ratio of tangible equity to total assets (d) Reclassifications based on guidance for industry entitled ‘‘Exempt
that is equal to or less than 2.0 percent. supervisory criteria other than capital. Infant Formula Production: Current
(c) Capital categories for insured The FDIC may reclassify a well Good Manufacturing Practices (CGMPs),
branches of foreign banks. For purposes capitalized FDIC-supervised institution Quality Control Procedures, Conduct of
of the provisions of section 38 of the FDI as adequately capitalized and may Audits, and Records and Reports.’’ The
Act and this subpart H, an insured require an adequately capitalized FDIC- guidance describes our current thinking
branch of a foreign bank shall be supervised institution or an on the manufacturing of exempt infant
deemed to be: undercapitalized FDIC-supervised formula in relation to the requirements
(1) ‘‘Well capitalized’’ if the insured institution to comply with certain for CGMPs, quality control procedures,
branch: mandatory or discretionary supervisory conduct of audits, and records and
(i) Maintains the pledge of assets
actions as if the FDIC-supervised reports that apply to non-exempt infant
required under § 347.209 of this chapter;
institution were in the next lower formulas.
and
(ii) Maintains the eligible assets capital category (except that the FDIC DATES: Submit either electronic or
prescribed under § 347.210 of this may not reclassify a significantly written comments on FDA guidances at
chapter at 108 percent or more of the undercapitalized FDIC-supervised any time.
preceding quarter’s average book value institution as critically ADDRESSES: You may submit comments
of the insured branch’s third-party undercapitalized) (each of these actions as follows:
liabilities; and are hereinafter referred to generally as
‘‘reclassifications’’) in the following Electronic Submissions
(iii) Has not received written
notification from: circumstances: Submit electronic comments in the
(A) The OCC to increase its capital (1) Unsafe or unsound condition. The following way:
equivalency deposit pursuant to 12 CFR FDIC has determined, after notice and • Federal eRulemaking Portal: http://
28.15, or to comply with asset opportunity for hearing pursuant to www.regulations.gov. Follow the
maintenance requirements pursuant to § 308.202(a) of this chapter, that the instructions for submitting comments.
12 CFR 28.20; or FDIC-supervised institution is in unsafe Comments submitted electronically,
(B) The FDIC to pledge additional or unsound condition; or including attachments, to http://
assets pursuant to § 347.209 of this (2) Unsafe or unsound practice. The www.regulations.gov will be posted to
chapter or to maintain a higher ratio of FDIC has determined, after notice and the docket unchanged. Because your
jstallworth on DSK7TPTVN1PROD with RULES
eligible assets pursuant to § 347.210 of opportunity for hearing pursuant to comment will be made public, you are
this chapter. § 308.202(a) of this chapter, that, in the solely responsible for ensuring that your
(2) ‘‘Adequately capitalized’’ if the most recent examination of the FDIC- comment does not include any
insured branch: supervised institution, the FDIC- confidential information that you or a
(i) Maintains the pledge of assets supervised institution received and has third party may not wish to be posted,
required under § 347.209 of this chapter; not corrected a less-than-satisfactory such as medical information, your or
and rating for any of the categories of asset anyone else’s Social Security number, or
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![Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Rules and Regulations 22175
confidential business information, such provide this information on the cover formulas. A final rule amending part
as a manufacturing process. Please note sheet and not in the body of your 106 was published in the Federal
that if you include your name, contact comments and you must identify this Register on June 10, 2014 (79 FR 33057).
information, or other information that information as ‘‘confidential.’’ Any In the Federal Register of February
identifies you in the body of your information marked as ‘‘confidential’’ 10, 2014 (79 FR 7610), we made
comments, that information will be will not be disclosed except in
available a draft guidance entitled
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment ‘‘Draft Guidance for Industry; Exempt
applicable disclosure law. For more
with confidential information that you information about FDA’s posting of Infant Formula Production: Current
do not wish to be made available to the comments to public dockets, see 80 FR Good Manufacturing Practices (CGMPs),
public, submit the comment as a 56469, September 18, 2015, or access Quality Control Procedures, Conduct of
written/paper submission and in the the information at: http://www.fda.gov/ Audits, and Records and Reports’’ and
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ gave interested parties an opportunity to
Submissions’’ and ‘‘Instructions’’). default.htm. submit comments by May 12, 2014, for
Docket: For access to the docket to us to consider before beginning work on
Written/Paper Submissions
read background documents or the the final version of the guidance. We
Submit written/paper submissions as electronic and written/paper comments received one comment on the draft
follows: received, go to http:// guidance, but the comment pertained to
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the infant formula ingredients and not to
written/paper submissions): Division of
docket number, found in brackets in the the guidance itself. Consequently, we
Dockets Management (HFA–305), Food
heading of this document, into the did not modify the guidance in response
and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts to the comment. However, we have
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments and/or go to the Division of Dockets modified the final guidance where
submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. appropriate to refer to the final rule that
Management, FDA will post your 1061, Rockville, MD 20852. was published in the Federal Register
comment, as well as any attachments, Submit written requests for single on June 10, 2014. The guidance
except for information submitted, copies of the guidance to the Office of announced in this notice finalizes the
marked and identified, as confidential, Nutrition and Food Labeling, Center for draft guidance dated February 2014.
if submitted as detailed in Food Safety and Applied Nutrition
(HFS–850), Food and Drug We are issuing this guidance
‘‘Instructions.’’ consistent with our good guidance
Instructions: All submissions received Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send practices regulation (21 CFR 10.115).
must include the Docket No. FDA–
two self-addressed adhesive labels to The guidance represents the current
2014–D–0044 for the ‘‘Exempt Infant
assist that office in processing your thinking of FDA on this topic. It does
Formula Production: Current Good
Manufacturing Practices (CGMPs), request. See the SUPPLEMENTARY not establish any rights for any person
Quality Control Procedures, Conduct of INFORMATION section for electronic and is not binding on FDA or the public.
Audits, and Records and Reports.’’ access to the guidance. You can use an alternative approach if
Received comments will be placed in FOR FURTHER INFORMATION CONTACT: it satisfies the requirements of the
the docket and, except for those Carrie L. Assar, Center for Food Safety applicable statutes and regulations.
submitted as ‘‘Confidential and Applied Nutrition (HFS–850), Food
II. Paperwork Reduction Act of 1995
Submissions,’’ publicly viewable at and Drug Administration, 5100 Paint
http://www.regulations.gov or at the Branch Pkwy., College Park, MD 20740, This guidance contains information
Division of Dockets Management 240–402–1453. collection provisions that are subject to
between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: review by the Office of Management and
through Friday. Budget (OMB) under the Paperwork
• Confidential Submissions—To I. Background
Reduction Act of 1995 (44 U.S.C. 3501–
submit a comment with confidential We are announcing the availability of 3520). The collections of information in
information that you do not wish to be a guidance for industry entitled 21 CFR part 106 have been approved
made publicly available, submit your ‘‘Exempt Infant Formula Production: under OMB control number 0910–0811.
comments only as a written/paper Current Good Manufacturing Practices
submission. You should submit two (CGMPs), Quality Control Procedures, III. Electronic Access
copies total. One copy will include the Conduct of Audits, and Records and
information you claim to be confidential Reports.’’ Section 412(h)(1) of the Persons with access to the Internet
with a heading or cover note that states Federal Food, Drug, and Cosmetic Act may obtain the guidance at http://
‘‘THIS DOCUMENT CONTAINS (the FD&C Act) (21 U.S.C. 350a(h)(1)) www.fda.gov/FoodGuidances or http://
CONFIDENTIAL INFORMATION.’’ The exempts an infant formula that is www.regulations.gov. Use the FDA Web
Agency will review this copy, including represented and labeled for use by an site listed in the previous sentence to
the claimed confidential information, in infant with an inborn error of find the most current version of the
its consideration of comments. The metabolism, low birth weight, or who guidance.
second copy, which will have the otherwise has an unusual medical or Dated: April 8, 2016.
claimed confidential information dietary problem from the requirements
Leslie Kux,
jstallworth on DSK7TPTVN1PROD with RULES
redacted/blacked out, will be available of sections 412(a), (b), and (c) of the
for public viewing and posted on http:// FD&C Act. These formulas are Associate Commissioner for Policy.
www.regulations.gov. Submit both customarily referred to as ‘‘exempt [FR Doc. 2016–08684 Filed 4–14–16; 8:45 am]
copies to the Division of Dockets infant formulas.’’ The guidance is BILLING CODE 4164–01–P
Management. If you do not wish your intended to describe the significance of
name and contact information to be the regulations in 21 CFR part 106 for
made publicly available, you can the production of exempt infant
VerDate Sep<11>2014 14:40 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4700 Sfmt 9990 E:\FR\FM\15APR1.SGM 15APR1](https://thefederalregister.org/doc/81_FR_22247/page/2.svg)
Document Created: 2016-04-15 00:55:14
Document Modified: 2016-04-15 00:55:14
| 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 | 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. | |
| FR Citation | 81 FR 22174 |
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