Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 65669 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued 

21 CFR Section Number of 

recordkeepers 

Number of records 

per recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

312.57, Sponsor recordkeeping showing 

the receipt, shipment, or other disposition of the investigational drug, and 

any financial interests.

335 2 .70 904 100 ................... 90,400 

312.62(a), Investigator recordkeeping of 

the disposition of drugs.

453 1 453 40 ..................... 18,120 

312.62(b), Investigator recordkeeping of 

case histories of individuals.

453 1 453 40 ..................... 18,120 

312.160(a)(3), Records pertaining to the 

shipment of drugs for investigational 

use in laboratory research animals or 

in vitro tests.

111 1 .40 155 0.50 (30 minutes).78 

312.160(c), Shipper records of alternative disposition of unused drugs.111 1 .40 155 0.50 (30 minutes).78 

Total ................................................. .............................. ................................ .............................. ........................... 127,006 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 31, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26304 Filed 11–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1119] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Canning 

Establishment Registration, Process 

Filing, and Recordkeeping for Acidified 

Foods and Thermally Processed LowAcid Foods in Hermetically Sealed 

Containers; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

correcting a notice that appeared in the 

Federal Register of August 14, 2014. 

The notice announced that a proposed 

collection of information had been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995. In this 

document, we correct some errors that 

appeared in the notice. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2014–19241, appearing on page 47642 

in the Federal Register of August 14, 

2014 (79 FR 47642), we make the 

following corrections: 

1. On page 47643, in the second 

column, in the Response to Comment 3, 

delete the sentence starting with ‘‘The 

scope of the voluntary submission . . . 

and the product label.’’ 

2. On page 47643, in the second 

column, in the Response to Comment 3, 

in the sentence starting with 

‘‘Consequently, we have proposed 

. . .,’’ delete ‘‘institute the voluntary 

consultation process discussed in this 

document’’ and replace it with ‘‘provide 

for the voluntary registration and Form 

FDA 2541e submission process’’. 

3. On page 47643, in the second and 

third columns, in the Response to 

Comment 3, delete the sentences 

starting with ‘‘The ability to submit a 

voluntary submission . . . of part 114’’ 

and the remaining sentences in the 

response and replace them with ‘‘FDA 

has authority to implement the 

voluntary submission process under 

sections 402 and 404 of the FD&C Act.’’ 

4. On page 47643, in the third 

column, in the Response to Comment 4, 

replace the response with the following: 

‘‘A voluntary process filing submission 

will not result in part 114 applying to 

products that are not acidified foods as 

defined in 21 CFR 114.3(b). Further, the 

voluntary process filing submission 

process will not result in any changes to 

part 114.’’ 

5. On pages 47643 to 47644, in the 

third column on page 47643 and in the 

first column on page 47644, in the 

Response to Comment 5, replace the 

response with the following: ‘‘Our 

inspectors will not expect all 

manufacturers to submit voluntary 

submissions.’’ 

6. On page 47644, in the first column, 

in the Response to Comment 7, replace 

the response with the following: ‘‘As 

discussed in the response to Comment 

4, if a product is not an acidified food, 

the product is not subject to the good 

manufacturing practice requirements in 

part 114 and will not become subject to 

those regulations as a result of a 

voluntary submission.’’ 

7. On page 47644, in the first and 

second columns, in the Response to 

Comment 8, replace the response with 

the following: ‘‘The draft guidance did 

address the issue of what constitutes a 

fermented food. We expect that the 

acidified foods guidance, when 

finalized, will provide guidance on 

what constitutes a fermented food.’’ 

8. On page 47644, in the second 

column, in the Response to Comment 9, 

replace the response with the following: 

‘‘Manufacturers are free to decide 

whether to make a voluntary 

submission, and we believe that some 

manufacturers may choose to do so. For 

FDA, the voluntary submission results 

in increased efficiency.’’ 

9. On page 47644, in the second and 

third columns, in the Response to 

Comment 10, delete the first paragraph 

of the response and delete the second 

sentence in the second paragraph of the 

response. 

10. On page 47645, in the first 

column, in the Response to Comment 

13, in the second sentence in the second 

paragraph of the response, delete ‘‘to 

prevent the detention of product’’. 

11. On page 47645, in the third 

column, in the Response to Comment 

20, in the first sentence of the response, 

replace ‘‘and provides’’ with ‘‘and, 

when finalized, will provide’’. 

mstockstill on DSK4VPTVN1PROD with NOTICES

65670 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 

12. On page 47646, in the first 

column, in the Response to Comment 

21, in the first sentence of the response, 

delete ‘‘from the coverage of part 114’’ 

and, at the end of the first sentence of 

the response, insert ‘‘or that do not 

otherwise meet the definitions of 

acidified food.’’ 

13. On page 47646, in the first 

column, in the Response to Comment 

22, replace the response with the 

following: ‘‘FDA does not agree that the 

‘Food Product Group’ categories in any 

way indicates FDA’s thinking as to 

whether all fruit and vegetable juices are 

acidified foods and are therefore subject 

to the acidified foods regulations in 

parts 108 and 114. Rather, the ‘Food 

Product Group’ categories are designed 

to help FDA understand the nature of 

products. For more information on what 

constitutes an acidified food, we 

recommend manufacturers consult the 

definition of acidified foods in 

§ 114.3(b).’’ 

14. On page 47646, in the second 

column, in the Response to Comment 

24, replace the second paragraph of the 

response with the following: ‘‘When 

optional information about the ‘Food 

Product Group’ category is provided, we 

will use it to help us understand the 

nature of the products and to help us 

prioritize which facilities to inspect.’’ 

Dated: October 30, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26238 Filed 11–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Oncology Subcommittee of the 

Oncologic Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 11, 2014, from 8 a.m. 

to 3:30 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Caleb Briggs, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

ODAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: Information will be 

presented to gauge investigator interest 

in exploring potential pediatric 

development plans for three products in 

various stages of development for adult 

cancer indications. The subcommittee 

will consider and discuss issues 

concerning diseases to be studied, 

patient populations to be included, and 

possible study designs in the 

development of these products for 

pediatric use. The discussion will also 

provide information to the Agency 

pertinent to the formulation of written 

requests for pediatric studies, if 

appropriate. The products under 

consideration are: (1) GANETESPIB, 

application submitted by Synta 

Pharmaceuticals Corp. (2) Etirinotecan, 

application submitted by Nektar 

Therapeutics, and (3) RO5503781, 

application submitted by Hoffmann-La 

Roche, Inc. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before December 3, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

8:55 a.m. to 9:15 a.m., 11:10 a.m. to 

11:30 a.m., and 2:10 p.m. to 2:30 p.m. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 25, 2014. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 26, 2014. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Caleb Briggs 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

mstockstill on DSK4VPTVN1PROD with NOTICES