75570 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

1. Notification of All Important 

Proposed Changes to Production and 

Facilities 

Each licensed manufacturer in a 

divided manufacturing arrangement or 

shared manufacturing arrangement must 

notify the appropriate FDA Center 

regarding proposed changes in the 

manufacture, testing, or specifications of 

its product, in accordance with § 601.12 

(21 CFR 601.12). In the guidance, we 

recommend that each licensed 

manufacturer that proposes such a 

change should also inform other 

participating licensed manufacturer(s) 

of the proposed change. 

For contract manufacturing 

arrangements, we recommend that the 

contract manufacturer should share 

with the license manufacturer all 

important proposed changes to 

production and facilities (including 

introduction of new products or at 

inspection). The license holder is 

responsible for reporting these changes 

to FDA (§ 601.12). 

2. Notification of Results of Tests and 

Investigations Regarding or Possibly 

Impacting the Product 

In the guidance, we recommend the 

following for contract manufacturing 

arrangements: 

• The contract manufacturer should 

fully inform the license manufacturer of 

the results of all tests and investigations 

regarding or possibly having an impact 

on the product; and 

• The license manufacturer should 

obtain assurance from the contractor 

that any FDA list of inspectional 

observations will be shared with the 

license manufacturer to allow 

evaluation of its impact on the purity, 

potency, and safety of the license 

manufacturer’s product. 

3. Notification of Products 

Manufactured in a Contract Facility 

In the guidance, we recommend for 

contract manufacturing arrangements 

that a license manufacturer cross 

reference a contract manufacturing 

facility’s Master Files only in 

circumstances involving certain 

proprietary information of the contract 

manufacturer, such as a list of all 

products manufactured in a contract 

facility. In this situation, the license 

manufacturer should be kept informed 

of the types or categories of all products 

manufactured in the contract facility. 

4. Standard Operating Procedures 

In the guidance, we remind the 

license manufacture that the license 

manufacturer assumes responsibility for 

compliance with the applicable product 

and establishment standards (21 CFR 

600.3(t)). Therefore, if the license 

manufacturer enters into an agreement 

with a contract manufacturing facility, 

the license manufacturer must ensure 

that the facility complies with the 

applicable standards. An agreement 

between a license manufacturer and a 

contract manufacturing facility normally 

includes procedures to regularly assess 

the contract manufacturing facility’s 

compliance. These procedures may 

include, but are not limited to, review 

of records and manufacturing deviations 

and defects, and periodic audits. 

For shared manufacturing 

arrangements, each manufacturer must 

submit a separate biologics license 

application describing the 

manufacturing facilities and operations 

applicable to the preparation of that 

manufacturer’s biological substance or 

product (§ 601.2(a)). In the guidance, we 

state that we expect the manufacturer 

that prepares (or is responsible for the 

preparation of) the product in final form 

for commercial distribution to assume 

primary responsibility for providing 

data demonstrating the safety, purity, 

and potency of the final product. We 

also state that we expect the licensed 

finished product manufacturer to be 

primarily responsible for any 

postapproval obligations, such as 

postmarketing clinical trials, additional 

product stability studies, complaint 

handling, recalls, postmarket reporting 

of the dissemination of advertising and 

promotional labeling materials as 

required under § 601.12(f)(4) and 

adverse experience reporting. We 

recommend that the final product 

manufacturer establish a procedure with 

the other participating manufacturer(s) 

to obtain information in these areas. 

Description of Respondents: The 

recordkeeping and reporting 

recommendations described in this 

document affect the participating 

licensed manufacturer(s), final product 

manufacturer(s), and contract 

manufacturer(s) associated with 

cooperative manufacturing 

arrangements. 

Burden Estimate: We believe that the 

information collection provisions in the 

guidance do not create a new burden for 

respondents. We believe the reporting 

and recordkeeping provisions are part of 

usual and customary business practices. 

Licensed manufacturers would have 

contractual agreements with 

participating licensed manufacturers, 

final product manufacturers, and 

contract manufacturers, as applicable 

for the type of cooperative 

manufacturing arrangement, to address 

all these information collection 

provisions. 

The guidance also refers to previously 

approved collections of information 

found in FDA regulations at parts 201, 

207, 211, 600, 601, 606, 607, 610, 660, 

801, 803, 807, 809, and 820 (21 CFR 

parts 201, 207, 211, 600, 601, 606, 607, 

610, 660, 801, 803, 807, 809, and 820). 

The collections of information in 

§§ 606.121, 606.122, and 610.40 have 

been approved under OMB control 

number 0910–0116; § 610.2 has been 

approved under OMB control number 

0910–0206; §§ 600.12(e) and 600.80 

have been approved under OMB control 

number 0910–0308; §§ 601.2(a), 601.12, 

610.60 through 610.65, 610.67, 660.2(c), 

660.28(a) and (b), 660.35(a), (c) through 

(g), (i) through (m), 660.45, and 

660.55(a) and (b) have been approved 

under OMB control number 0910–0338; 

§§ 803.20, 803.50, and 803.53 have been 

approved under OMB control number 

0910–0437; and §§ 600.14 and 606.171 

have been approved under OMB control 

number 0910–0458. The current good 

manufacturing practice regulations for 

finished pharmaceuticals (part 211) 

have been approved under OMB control 

number 0910–0139; §§ 820.181 and 

820.184 have been approved under 

OMB control number 0910–0073; the 

establishment registration regulations 

(parts 207, 607, and 807) have been 

approved under OMB control numbers 

0910–0045, 0910–0052, and 0910–0625; 

and the labeling regulations (parts 201, 

801, and 809) have been approved 

under OMB control numbers 0910– 

0537, 0910–0572, and 0910–0485. 

In the Federal Register of July 7, 2014 

(79 FR 38318), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

We received no comments. 

Dated: December 11, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29611 Filed 12–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1953] 

Guidance for Industry on Providing 

Regulatory Submissions in Electronic 

Format—Submissions Under Section 

745A(a) of the Federal Food, Drug, and 

Cosmetic Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 75571 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Submissions Under Section 745A(a) of 

the Federal Food, Drug, and Cosmetic 

Act.’’ The guidance announced in this 

notice sets forth FDA’s interpretation of 

the Food and Drug Administration 

Safety and Innovation Act (FDASIA), 

which amended the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) to require 

that certain submissions under the 

FD&C Act and the Public Health Service 

Act be submitted in electronic format, 

beginning no earlier than 24 months 

after issuance of a final version of a 

guidance document specifying the 

format for such electronic submissions. 

This guidance describes how FDA 

interprets and plans to implement the 

electronic submission requirements and 

finalizes the draft guidance that was 

issued on February 6, 2014. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002 or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 71, Rm. 3128, 

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 documents. 

Submit electronic comments on the 

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: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1192, Silver Spring, 

MD 20993–0002, 

ronald.fitzmartin@fda.hhs.gov; or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Submissions Under 

Section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act.’’ Section 1136 

of FDASIA (Pub. L. 112–144), signed by 

the President on July 9, 2012, amended 

the FD&C Act to add section 745A, 

entitled ‘‘Electronic Format for 

Submissions’’ (21 U.S.C. 379k–1). Drug 

and biological product submissions are 

addressed in section 745A(a) of the 

FD&C Act. 

Section 745A(a)(1) of the FD&C Act 

describes the general scope of section 

745A(a) and provides that submissions 

under new drug applications (NDAs), 

abbreviated new drug applications 

(ANDAs), biologics license applications 

(BLAs), and investigational new drug 

applications (INDs) must be in 

electronic format specified in FDA 

guidance. Section 745A(a)(2) of the 

FD&C Act states that the guidance 

issued by FDA may provide a timetable 

for future standards and criteria for 

waivers and exemptions. Section 

745A(a)(3) of the FD&C Act provides 

that the electronic submission 

requirements in section 745A(a) do not 

apply to submissions under section 561 

of the FD&C Act (21 U.S.C.360bbb). 

This guidance describes FDA’s 

interpretation of the scope of section 

745A(a) of the FD&C Act. It announces 

that certain INDs will be exempted from 

the electronic submission requirements. 

Finally, it describes the process and 

timetable that FDA will use to 

implement the electronic submission 

requirements. As described in the 

guidance, FDA will develop individual 

guidances to specify the electronic 

formats for certain types of submissions 

under section 745A(a). Under section 

745A(a)(1) of the FD&C Act, electronic 

submissions can be required no earlier 

than 24 months after FDA issues a final 

guidance. Therefore, no earlier than 24 

months after issuance of the final 

version of an individual guidance 

specifying the format for certain types of 

submissions under section 745A(a) of 

the FD&C Act, the Agency will begin 

requiring that the submissions under 

NDAs, ANDAs, certain BLAs, and 

certain INDs be submitted in the 

specified electronic format for the types 

of submissions described in that 

guidance. 

Individual guidances will be 

developed to specify the electronic 

formats, subject matter, and scope of 

applicability for certain submissions 

under section 745A(a) of the FD&C Act. 

Once an individual guidance is 

finalized and the timetable for 

implementation described in that 

guidance has passed, the guidance will 

have binding effect and the electronic 

format(s) specified in that guidance 

must be used for submissions to NDAs, 

ANDAs, certain BLAs, and certain INDs. 

In the Federal Register of February 6, 

2014 (79 FR 7200), FDA announced a 

draft version of this guidance entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Submissions Under 

Section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act.’’ The comment 

period on the draft guidance ended on 

May 6, 2014. We reviewed all comments 

received on the draft guidance and 

revised several sections of the guidance. 

The updates include: 

Section III.A and III.B: Clarified that 

the scope of the requirement under 

section 754A(a) does not extend to 

certain INDs and certain BLAs. Also 

clarified that certain INDs are exempted 

from the electronic submission 

requirements under section 745A(a)(2). 

Specifically, we clarified that INDs and 

BLAs for devices that are regulated by 

CBER as biological products under 

Section 351 of the Public Health Service 

(PHS) Act are instead subject to the 

requirements under Section 745A(b), 

and that, issued in section 745A(a)(2), 

INDs that are noncommercial are 

exempt from the requirements under 

section 745A(a). We provided examples 

in this regard. 

Section III.D: Clarified that the 

individual guidances under 745A(a) 

will specify electronic formats, subject 

matter, and scope of applicability, as 

well as the timetable for 

implementation. 

Section III.F: Clarified the timetable 

under which revisions or updates to 

electronic submission standards will 

take effect. 

FDA guidances ordinarily contain 

standard language explaining that 

guidances should be viewed only as 

recommendations unless specific 

regulatory or statutory requirements are 

cited. FDA is not including this 

standard language in this guidance 

because this guidance contains binding 

provisions. In section 745A(a) of the 

FD&C Act, Congress granted explicit 

authorization to FDA to specify in 

guidance the format for the electronic 

submissions required under that 

section. Accordingly, this guidance 

explains such requirements under 

section 745A(a) of the FD&C Act, 

indicated by the use of the words must 

or required, and therefore is not subject 

to the usual restrictions in FDA’s good 

guidance practice regulations, such as 

the requirement that guidances not 

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75572 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

establish legally enforceable 

responsibilities. See 21 CFR 10.115(d). 

II. Paperwork Reduction Act of 1995 

This guidance contains no collection 

of information. As discussed in the 

guidance, FDA intends to develop 

individual guidances to specify the 

electronic formats for certain 

submissions under section 745A(a) of 

the FD&C Act. We will discuss any 

information collection subject to 

clearance by OMB under the Paperwork 

Reduction Act in each Federal Register 

notice announcing the availability of the 

individual guidances that specify the 

required electronic formats. 

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 http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: December 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29609 Filed 12–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for 

Complementary and Alternative 

Medicine. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Complementary and Alternative 

Medicine 

Date: February 6, 2015. 

Closed: 8:30 a.m. to 9:45 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Open: 10:00 a.m. to 4:00 p.m. 

Agenda: Report from the Institute Director 

and other staff. 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Martin H. Goldrosen, 

Ph.D., Director, Division of Extramural 

Activities, National Center for 

Complementary and Alternative Medicine, 

NIH, 6707 Democracy Blvd., Ste. 401, 

Bethesda, MD 20892–5475, (301) 594–2014, 

goldrosm@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

nccam.nih.gov/about/naccam/, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: December 12, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–29571 Filed 12–17–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development (NICHD); Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Child Health and 

Human Development Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. A 

portion of this meeting will be closed to 

the public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended for the review and 

discussion of grant applications. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the contact person listed below in 

advance of the meeting. 

Name of Committee: National Advisory 

Child Health and Human Development 

Council. 

Date: January 22, 2015. 

Open: January 22, 2015, 8:00 a.m. to 12:10 

p.m. 

Agenda: Report of the Director, NICHD; 

Report of the Acting Director, Division of 

Extramural Research, NICHD; Discussion of 

the Outstanding Investigator Award (R35); 

and New Business of the Council. 

Closed: January 22, 2015, 1:15 p.m. to 

Adjournment. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Center Drive, C-Wing, 

Conference Room 6, Bethesda, MD 20892. 

Contact Person: Caroline Signore, MD., 

Mp.H., Acting Director, Division of 

Extramural Research, Eunice Kenney Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 4A05, MSC 7510, Bethesda, MD 

20892, (301) 496–5577. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the contact person listed on 

this notice. The statement should include the 

name, address, telephone number, and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

mstockstill on DSK4VPTVN1PROD with NOTICES