Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83091 

collection, changes compared to before 

COVID–19 began, and what has been 

challenging or worked well. The study 

will use surveys and interviews with 

center directors, FCC providers, and 

coaches. The sample frame will be 

comprised of respondents to the 2019 

survey. 

Respondents: ECE center directors, 

coaches, and FCC providers who 

responded to 2019 SCOPE surveys. 

Annual Burden Estimates 

Data collection will be completed 

within a 1-year period. 

Instrument 

Number of 

respondents 

(total over request period) 

Number of 

responses per 

respondent 

(total over request period) 

Average 

Burden per response (in 

hours) 

Total/Annual 

burden (in 

hours) 

Coach Survey (Instrument 1) ........................................................................ 100 1 .33 33 

Center Director Survey (Instrument 2) .......................................................... 66 1 .33 22 

FCC Provider Survey (Instrument 3) ............................................................. 38 1 .33 13 

Coach Interview (Instrument 4) ..................................................................... 12 1 .75 9 

Center Director Interview (Instrument 5) ....................................................... 24 1 .75 18 

FCC Provider Interview (Instrument 6): FCC providers ................................ 12 1 .75 9 

Estimated Total Annual Burden 

Hours: 104. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate

of the burden of the proposed collection

of information; (c) the quality, utility,

and clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology. Consideration will be given

to comments and suggestions submitted

within 60 days of this publication.

Authority: 42 U.S.C. 9858(a)(5), 42 U.S.C. 

9835, and 42 U.S.C. 9844. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–28043 Filed 12–18–20; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration-Regulated 

Products: Export Certificates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 20, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0498. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Export of Food and Drug 

Administration-Regulated Products: 

Export Certificates 

OMB Control Number 0910–0498— 

Extension 

Sections 801(e) and 802 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 381(e) and 382) pertain 

to the export of FDA-regulated products 

and are intended to ease restrictions on 

exportation. The provisions also require 

the Agency to issue written export 

certifications within 20 days of any 

request. In January 2011, section 

801(e)(4)(A) was amended by the FDA 

Food Safety Modernization Act (Pub. L. 

111–353) to provide authorization for 

export certification for food and animal 

feed, as well as certain unapproved 

products. To offset Agency resource 

expenditures for processing 

certifications requests, the statute 

provides that FDA may charge firms a 

fee not to exceed $175. 

There are four FDA forms (Form FDA 

3613, 3613a, 3613b, and 3613c) related 

to exporting FDA-regulated products. A 

description of each form is provided 

below. To obtain a fillable PDF file of 

each form, visit https://www.fda.gov/ 

vaccines-blood-biologics/exporting-cberregulated-products/fda-formscertificates-exporting. To learn more 

about how to complete these forms, visit 

https://www.fda.gov/vaccines-bloodbiologics/exporting-cber-regulatedproducts/how-complete-fda-exportcertificate-forms. 

83092 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

TABLE 1—CERTIFICATES AND USES

Type of certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests‘‘.

‘‘Exporter’s Certification Statement Certificate to Foreign Government‘‘. 

‘‘Exporter’s Certification Statement Certificate to Foreign Government 

(For Human Tissue Intended for Transplantation)‘‘..

For the export of products legally marketed in the United States. 

‘‘Supplementary Information Certificate of Exportability Requests‘‘ ........

Exporter’s Certification Statement Certificate of Exportability‘‘. ...............

For the export of products not approved for marketing in the United 

States (unapproved products) that meet the requirements of sections 

801(e) or 802 of the FD&C Act. 

‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘ ...

‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical 

Product‘‘.

Conforms to the format established by the World Health Organization 

and is intended for use by the importing country when the product in 

question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or 

reviewing a license. 

‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘.

‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)‘‘

For the export of a non-clinical research use only product, material, or 

component that is not intended for human use and which may be 

marketed in, and legally exported from the United States under the 

FD&C Act. 

Appropriate centers within FDA 

review product information submitted 

by firms in support of the firms’ 

certificate requests. We rely on 

respondents to certify their compliance 

with all applicable requirements of the 

FD&C Act both at the time the 

certification request is submitted to FDA 

and at the time the certification is 

submitted to the respective foreign 

government. Information regarding 

FDA’s Export Certificates may be found 

on our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/fda-exportcertificates. 

On September 16, 2020, we submitted 

an information collection request to the 

Office of Management and Budget 

(OMB) to revise certain data elements as 

may be applicable under the 

Coronavirus Aid, Relief, and Economic 

Security Act (CARES Act). Because 

Section 3856 of the CARES Act 

contained immediately effective 

provisions obligating FDA to review and 

process certification requests, we 

requested emergency processing by 

OMB under 5 CFR 1320.13 for the 

respective information collection. Our 

information collection request was 

granted by OMB on September 29, 2020. 

Therefore, in accordance with 5 CFR 

1320.8(d)(1), we invite comment on the 

burden we attribute to the information 

collection, which we estimate as 

follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1

FDA center Number of 

Respondents 

Number of 

Responses 

per Respondent 

Total Anual 

responses 

Average burden per 

response 

Total hours 

Center for Biologics Evaluation and Research .................... 2,651 1 2,651 1 2,651 

Center for Devices and Radiological Health ....................... 11,175 1 11,175 2 22,350 

Center for Drug Evaluation and Research .......................... 3,680 1 3,680 1 3,680 

Center for Veterinary Medicine ............................................ 1,925 1 1,925 1 1,925 

Total .............................................................................. ........................ ........................ ........................ ........................ 30,606 

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

Based on our current evaluation of the 

information collection, we have made 

no adjustments since our last request for 

OMB review and approval. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28064 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2217] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Animal Drugs 

for Investigational Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, 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 (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 reporting and 

recordkeeping requirements of our 

regulations concerning new animal 

drugs for investigational use. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 19, 2021.