80_FR_17118 80 FR 17057 - Development and Submission of Near Infrared Analytical Procedures; Draft Guidance for Industry; Availability

80 FR 17057 - Development and Submission of Near Infrared Analytical Procedures; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range17057-17058
FR Document2015-07266

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Development and Submission of Near Infrared Analytical Procedures.'' This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration.

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015) 
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17057-17058]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0868]


Development and Submission of Near Infrared Analytical 
Procedures; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Development 
and Submission of Near Infrared Analytical Procedures.'' This draft 
guidance provides recommendations to applicants of new drug 
applications (NDAs) and abbreviated new drug applications (ANDAs) 
regarding the development and submission of near infrared (NIR) 
analytical procedures used during the manufacture and analysis of 
pharmaceuticals. This draft guidance only pertains to the development 
and validation of NIR analytical procedures and does not provide 
recommendations concerning the set up and qualification of NIR 
instruments or their maintenance and calibration.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 1, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John L. Smith, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1757.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Development and Submission of Near Infrared Analytical 
Procedures.'' This draft guidance provides recommendations to 
applicants of NDAs and ANDAs regarding the development and submission 
of NIR analytical procedures used during the manufacture and analysis 
of pharmaceuticals (including raw materials, in-process materials and 
intermediates, and finished products). It also provides recommendations 
regarding how the concepts described in the International Conference on 
Harmonisation (ICH) guidance for industry, ``Q2(R1) Validation of 
Analytical Procedures: Text and Methodology'' (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm265700.htm) 
and ``PAT--A Framework for Innovative Pharmaceutical Development, 
Manufacturing, and Quality Assurance'' (http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf) can be applied to the development, 
validation,

[[Page 17058]]

and submission of NIR analytical procedures.
    This draft guidance only pertains to the development and validation 
of NIR analytical procedures and does not provide recommendations 
concerning the set up and qualification of NIR instruments or their 
maintenance and calibration.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the submission 
and development of NIR analytical procedures. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information 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 314 for NDAs, 
ANDAs, supplements to applications, and annual reports have been 
approved under OMB control number 0910-0001.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07266 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17057 On May 1, 2015, the committee will Articles of Food in Vending Machines’’ the set up and qualification of NIR discuss key issues related to a potential has been approved by the Office of instruments or their maintenance and pre- to postmarket shift in clinical data Management and Budget (OMB) under calibration. requirements for modifications to the Paperwork Reduction Act of 1995. DATES: Although you can comment on cochlear implants in pediatric patients. FOR FURTHER INFORMATION CONTACT: FDA any guidance at any time (see 21 CFR These issues are categorized into three PRA Staff, Office of Operations, Food 10.115(g)(5)), to ensure that the Agency broad areas for discussion: and Drug Administration, 8455 considers your comment on this draft 1. Cochlear implant changes (e.g. Colesville Rd., COLE–14526, Silver guidance before it begins work on the sound processing features, patient Spring, MD 20993–0002, PRAStaff@ final version of the guidance, submit characteristics) that may be suitable for fda.hhs.gov. either electronic or written comments this pre- to postmarket shift in clinical on the draft guidance by June 1, 2015. SUPPLEMENTARY INFORMATION: On data requirements. ADDRESSES: Submit written requests for 2. Appropriate premarket clinical data February 5, 2015, the Agency submitted a proposed collection of information single copies of the draft guidance to the requirements to support pre- to entitled ‘‘Food Labeling; Calorie Division of Drug Information, Center for postmarket shift (e.g. leveraging clinical Labeling of Articles of Food in Vending Drug Evaluation and Research, Food data from adults and/or older children.) 3. Clinical study design Machines’’ to OMB for review and and Drug Administration, 10001 New clearance under 44 U.S.C. 3507. An Hampshire Ave., Hillandale Building, considerations (e.g. study endpoints and Agency may not conduct or sponsor, 4th Floor, Silver Spring, MD 20993– test metrics, subject characteristics) for and a person is not required to respond 0002. Send one self-addressed adhesive postmarket studies to confirm safety and to, a collection of information unless it label to assist that office in processing effectiveness and inform future labeling. FDA intends to make background displays a currently valid OMB control your requests. See the SUPPLEMENTARY number. OMB has now approved the INFORMATION section for electronic material available to the public no later than 2 business days before the meeting. information collection and has assigned access to the draft guidance document. OMB control number 0910–0782. The Submit electronic comments on the If FDA is unable to post the background approval expires on March 31, 2018. A draft guidance to http:// material on its Web site prior to the copy of the supporting statement for this www.regulations.gov. Submit written meeting, the background material will information collection is available on comments to the Division of Dockets be made publicly available at the the Internet at http://www.reginfo.gov/ Management (HFA–305), Food and Drug location of the advisory committee public/do/PRAMain. Administration, 5630 Fishers Lane, Rm. meeting, and the background material 1061, Rockville, MD 20852. will be posted on FDA’s Web site after Dated: March 25, 2015. FOR FURTHER INFORMATION CONTACT: John the meeting. Background material is Leslie Kux, available at http://www.fda.gov/ L. Smith, Center for Drug Evaluation Associate Commissioner for Policy. and Research, Food and Drug AdvisoryCommittees/Calendar/ [FR Doc. 2015–07265 Filed 3–30–15; 8:45 am] default.htm. Scroll down to the Administration, 10903 New Hampshire appropriate advisory committee meeting BILLING CODE 4164–01–P Ave., Silver Spring, MD 20993–0002, link. 301–796–1757. This notice is issued under the SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND Federal Advisory Committee Act (5 HUMAN SERVICES I. Background U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. FDA is announcing the availability of Food and Drug Administration a draft guidance for industry entitled Dated: March 24, 2015. [Docket No. FDA–2015–D–0868] ‘‘Development and Submission of Near Jill Hartzler Warner, Infrared Analytical Procedures.’’ This Associate Commissioner for Special Medical Development and Submission of Near draft guidance provides Programs. Infrared Analytical Procedures; Draft recommendations to applicants of NDAs [FR Doc. 2015–07300 Filed 3–30–15; 8:45 am] Guidance for Industry; Availability and ANDAs regarding the development BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, and submission of NIR analytical HHS. procedures used during the manufacture ACTION: Notice. and analysis of pharmaceuticals DEPARTMENT OF HEALTH AND (including raw materials, in-process HUMAN SERVICES SUMMARY: The Food and Drug materials and intermediates, and Administration (FDA) is announcing the finished products). It also provides Food and Drug Administration availability of a draft guidance for recommendations regarding how the [Docket No. FDA–2011–F–0171] industry entitled ‘‘Development and concepts described in the International Submission of Near Infrared Analytical Conference on Harmonisation (ICH) Agency Information Collection Procedures.’’ This draft guidance guidance for industry, ‘‘Q2(R1) Activities; Announcement of Office of provides recommendations to Validation of Analytical Procedures: Management and Budget Approval; applicants of new drug applications Text and Methodology’’ (http:// Food Labeling; Calorie Labeling of (NDAs) and abbreviated new drug www.fda.gov/Drugs/ Articles of Food in Vending Machines applications (ANDAs) regarding the GuidanceCompliance asabaliauskas on DSK5VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, development and submission of near RegulatoryInformation/Guidances/ HHS. infrared (NIR) analytical procedures ucm265700.htm) and ‘‘PAT—A ACTION: Notice. used during the manufacture and Framework for Innovative analysis of pharmaceuticals. This draft Pharmaceutical Development, SUMMARY: The Food and Drug guidance only pertains to the Manufacturing, and Quality Assurance’’ Administration (FDA) is announcing development and validation of NIR (http://www.fda.gov/downloads/Drugs/ that a collection of information entitled analytical procedures and does not Guidances/ucm070305.pdf) can be ‘‘Food Labeling; Calorie Labeling of provide recommendations concerning applied to the development, validation, VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1

17058 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices and submission of NIR analytical DEPARTMENT OF HEALTH AND CB has interpreted the law to prohibit procedures. HUMAN SERVICES a title IV–E agency from automatically This draft guidance only pertains to suspending a title IV–E adoption Administration for Children and assistance payment on the basis that the development and validation of NIR Families suspending title IV–E adoption analytical procedures and does not provide recommendations concerning assistance is equivalent to terminating Notice for Public Comment on the Title title IV–E adoption assistance. See Child the set up and qualification of NIR IV–E Adoption Assistance Program’s instruments or their maintenance and Welfare Policy Manual, section 8.2D.5, Suspension and Termination Policies Question and Answer #3 (available at calibration. AGENCY: Children’s Bureau; http://www.acf.hhs.gov/cwpm/ This draft guidance is being issued Administration on Children, Youth and programs/cb/laws_policies/laws/cwpm/ consistent with FDA’s good guidance Families; ACF, HHS policy_dsp.jsp?citID=82#747). practices regulation (21 CFR 10.115). ACTION: Notice. The statute also requires adoptive The draft guidance, when finalized, will parents to keep the title IV–E agency represent the current thinking of FDA SUMMARY: In accordance with title IV–E apprised of any circumstances that on the submission and development of of the Social Security Act (42 U.S.C. would impact a child’s continued NIR analytical procedures. It does not 673), the Children’s Bureau (CB) eligibility for title IV–E adoption establish any rights for any person and announces the opportunity for public assistance, or would impact the is not binding on FDA or the public. comment on our suspension and appropriate amount of the payment. See You can use an alternative approach if termination policies for the title IV–E the Social Security Act at sec. it satisfies the requirements of the adoption assistance program, articulated 473(a)(4)(B). However, the statute does applicable statutes and regulations. in the Child Welfare Policy Manual. We not specify a recourse for title IV–E similarly announce the opportunity to agencies if a parent does not provide II. The Paperwork Reduction Act of provide public comment about any such information. CB has explained in 1995 other policy areas of concern relating to the Child Welfare Policy Manual that the title IV–E adoption assistance title IV–E agencies may not suspend or This guidance refers to previously program. terminate title IV–E adoption assistance approved collections of information that are subject to review by the Office of DATES: Submit written or electronic if adoptive parents do not respond to Management and Budget (OMB) under comments on or before June 29, 2015. requests for information about whether the Paperwork Reduction Act of 1995 ADDRESSES: Interested persons may the parents are providing any support to (44 U.S.C. 3501–3520). The collections submit comments to http:// the child, or whether the adoptive of information in 21 CFR part 314 for www.regulations.gov/. We urge you to parents remain legally responsible for NDAs, ANDAs, supplements to submit comments electronically to their adopted child. See Child Welfare applications, and annual reports have ensure they are received in a timely Policy Manual, section 8.2, Question been approved under OMB control manner. Written comments may also be and Answer #1 (http://www.acf.hhs.gov/ number 0910–0001. submitted to Kathleen McHugh, United cwpm/programs/cb/laws_policies/laws/ States Department of Health and Human cwpm/policy_dsp.jsp?citID=63). III. Comments Services, Administration for Children We seek comment from title IV–E and Families, Policy Division, 8th Floor, agencies and other stakeholders about Interested persons may submit either 1250 Maryland Avenue SW., the title IV–E adoption assistance electronic comments regarding this Washington, DC 20024. suspension and termination policies. document to http://www.regulations.gov We invite agencies and stakeholders to FOR FURTHER INFORMATION CONTACT: or written comments to the Division of share their experiences and concerns Kathleen McHugh, United States Dockets Management (see ADDRESSES). It Department of Health and Human about how title IV–E agencies is only necessary to send one set of Services, Administration for Children implement the suspension and comments. Identify comments with the and Families, Policy Division, 8th Floor, termination policies, and any docket number found in brackets in the 1250 Maryland Avenue SW., difficulties they have had ensuring that heading of this document. Received Washington, DC 20024. Email address: they are paying title IV–E adoption comments may be seen in the Division cbcomments@acf.hhs.gov. assistance funds appropriately. of Dockets Management between 9 a.m. In particular, we encourage SUPPLEMENTARY INFORMATION: The Social and 4 p.m., Monday through Friday, and Security Act only permits a title IV–E respondents to address the following will be posted to the docket at http:// agency to terminate a child or youth’s questions: www.regulations.gov. title IV–E adoption assistance subsidy (1) Should jurisdictions have IV. Electronic Access under three delineated circumstances: authority to suspend adoption (1) The child has attained the age of 18, assistance payments under any Persons with access to the Internet or the age that the agency has chosen circumstances? If so, what specific may obtain the document at either pursuant to sec. 475(8)(B)(iii) and (iv) of circumstances should be the basis for http://www.fda.gov/Drugs/ the Social Security Act (or the age of 21 suspension? GuidanceCompliance if the title IV–E agency has determined (2) If suspension was to be permitted, RegulatoryInformation/Guidances/ that the child has a mental or physical what processes should be required in asabaliauskas on DSK5VPTVN1PROD with NOTICES default.htm or http:// disability which would warrant connection with suspension, and what www.regulations.gov. continuation of assistance); (2) the title processes should be required for Dated: March 25, 2015. IV–E agency determines that the reinstatement? adoptive parents are no longer legally More generally, we invite title IV–E Leslie Kux, responsible for support of the child; or agencies and other stakeholders to share Associate Commissioner for Policy. (3) the title IV–E agency determines that their broader concerns about the title [FR Doc. 2015–07266 Filed 3–30–15; 8:45 am] the adoptive parents are no longer IV–E adoption assistance program that BILLING CODE 4164–01–P providing any support to the child. are unrelated to suspending or VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1


Document Created: 2015-12-18 11:48:15
Document Modified: 2015-12-18 11:48:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015.
ContactJohn L. Smith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1757.
FR Citation80 FR 17057 
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