Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4921 

TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued 

21 CFR Section Number of 

recordkeepers 

First year 

frequency of 

recordkeeping 

Total records Hours per 

record Total hours 

7. Controls to Prevent Adulteration by Equipment or Utensils 106.30(d)(1) and 106.100(f)(2) .................................. 3 52 156 0.21 32.76 

8. Controls to Prevent Adulteration by Equipment or Utensils 106.30(e)(3)(iii) and 106.100(f)(3) ............................. 3 52 156 0.21 32.76 

9. Controls to Prevent Adulteration by Equipment or Utensils 106.30(f)(2) and 106.100(f)(4) ................................... 3 52 156 0.19 29.64 

10. Controls to Prevent Adulteration Due to Automatic 

(Mechanical or Electronic) Equipment 106.35(c) and 

106.100(f)(5) ..................................................................... 3 52 3 520 1,560 

11. Controls to Prevent Adulteration Due to Automatic 

(Mechanical or Electronic) Equipment 106.35(c) and 

106.100(f)(5) ..................................................................... 12 2 6 640 3,840 

12. Controls to Prevent Adulteration Caused by Ingredients, Containers, and Closures 106.40(g) and 

106.100(f)(6) ..................................................................... 3 52 156 0.17 26.52 

13. Controls to Prevent Adulteration During Manufacturing 

106.50 and 106.100(e) ..................................................... 3 52 156 0.23 35.88 

14. Controls to Prevent Adulteration From Microorganisms 

106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7) ................ 3 52 156 0.25 39 

15. Controls to Prevent Adulteration During Packaging and 

Labeling of Infant Formula 106.60(c) ............................... 1 12 12 0.25 3 

16. General Quality Control-Testing 106.91(b)(1) through 

(3) ..................................................................................... 2 1 2 2 4 

17. General Quality Control 106.91(b)(1) and (d), and 

106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 

18. General Quality Control 106.91(b)(2) and (d), and 

106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 

19. General Quality Control 106.91(b)(3) and (d), and 

106.100(e)(5)(i) ................................................................. 2 52 104 0.15 15.6 

20. Audit Plans and Procedures 106.94—Ongoing Review 

and Updating of Audits ..................................................... 3 1 3 8 24 

21. Audit Plans and Procedures 106.94—Regular Audits .. 3 52 156 4 624 

Total Recurring Recordkeeping Burden ....................... ........................ ........................ ........................ ........................ 6,328.06 

Total Recordkeeping Burden ........................................ ........................ ........................ ........................ ........................ 25,648.06 

1As noted previously, the burden for making and maintaining such records is expected to occur once every 4 years. The total hours column 

reflects the total number of hours averaged over the 4 year period. 2As noted previously, the burden for making and maintaining such records is expected to occur once every four years. The total hours column 

reflects the total number of hours averaged over the four-year period. 

III. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Zink, Don. Statement of Donald L. Zink: 

Infant Formula Manufacturing Practices, 

2013. 

Dated: January 22, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01690 Filed 1–27–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0380] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Product 

Jurisdiction: Assignment of Agency 

Component for Review of Premarket 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the procedure by which an applicant 

may obtain an assignment or 

designation determination for 

combination products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 28, 2016. 

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 


wgreen on DSK2VPTVN1PROD with NOTICES
4922 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 

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 

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– 

2009–N–0380 for ‘‘Product Jurisdiction: 

Assignment of Agency Component for 

Review of Premarket Applications.’’ 

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. 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Product Jurisdiction: Assignment of 

Agency Component for Review of 

Premarket Applications 21 CFR Part 3 

(OMB Control Number 0910–0523)— 

Extension 

This regulation relates to Agency 

management and organization and has 

two purposes. The first is to implement 

section 503(g) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 353(g)), as 

added by the Safe Medical Devices Act 

of 1990 (Pub. L. 101–629), and amended 

by the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), by specifying how FDA will 

determine the organizational component 

within FDA assigned to have primary 

jurisdiction for the premarket review 

and regulation of products that are 

comprised of any combination of: (1) A 

drug and a device; (2) a device and a 

biological product; (3) a biological 

product and a drug; or (4) a drug, a 

device, and a biological product. The 

second purpose of this regulation is to 

enhance the efficiency of Agency 

management and operations by 

providing procedures for classifying and 

determining which Agency component 

is designated to have primary 

jurisdiction for any drug, device, or 

biological product where such 

jurisdiction is unclear or in dispute. 

The regulation establishes a 

procedure by which an applicant may 

obtain an assignment or designation 

determination. The regulation requires 

that the request include the identity of 

the applicant, a comprehensive 

description of the product and its 

proposed use, and the applicant’s 

recommendation as to which Agency 

component should have primary 

jurisdiction, with an accompanying 

statement of reasons. The information 

submitted would be used by FDA as the 

basis for making the assignment or 

designation decision. Most information 

required by the regulation is already 

required for premarket applications 

affecting drugs, devices, biological 

products, and combination products. 

The respondents will be businesses or 

other for-profit organizations. 

FDA estimates the burden of this 

collection of information as follows: 


wgreen on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4923 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Part Number of 

respondents 

Numberr of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

3 84 1 84 24 2,016 

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

These burden estimates are based on 

the number of applications FDA 

received over the past fiscal year. 

Dated: January 25, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01684 Filed 1–27–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0297] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prevention of 

Salmonella Enteritidis in Shell Eggs 

During Production; Recordkeeping and 

Registration Provisions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (the PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of FDA’s 

recordkeeping and registration 

requirements for shell egg producers. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 28, 2016. 

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 

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– 

2013–N–0297 for Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Prevention of Salmonella Enteritidis in 

Shell Eggs During Production— 

Recordkeeping and Registration 

Provisions. 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. 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 


wgreen on DSK2VPTVN1PROD with NOTICES