34018 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 

Effective Date 

This Order is effective on July 1, 2021, 

and will remain in effect through July 

31, 2021, subject to revision based on 

the changing public health landscape. 

Authority 

The authority for this Order is Section 

361 of the Public Health Service Act (42 

U.S.C. 264) and 42 CFR 70.2. 

Dated: June 24, 2021. 

Sherri Berger, 

Chief of Staff, Centers for Disease Control 

and Prevention. 

[FR Doc. 2021–13842 Filed 6–24–21; 2:00 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Community Services Block Grant 

(CSBG) Model State Plan Applications 

(OMB No. 0970–0382) 

AGENCY: Office of Community Services, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Office of Community 

Services (OCS) requests a three-year 

extension of the forms Community 

Services Block Grant (CSBG) State Plan, 

CSBG Eligible Entity Master List, and 

the American Customer Survey Index 

(ACSI) (OMB #0970–0382, expiration 

6/30/2021). There are minimal changes 

requested to the State Plan and the 

Master List. No changes are proposed to 

the ACSI. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: Section 676 of the 

Community Services Block Grant 

(CSBG) Act requires states, including 

the District of Columbia and the 

Commonwealth of Puerto Rico, and U.S. 

territories applying for CSBG funds to 

submit an application and plan (CSBG 

State Plan). The CSBG State Plan must 

meet statutory requirements prior to 

CSBG grantees (states and territories) 

being funded with CSBG funds. 

Grantees have the option to submit a 

detailed plan annually or biannually. 

Grantees that submit a biannual plan 

must provide an abbreviated plan the 

following year if substantial changes to 

the initial plan will occur. 

OCS proposes to revise the automated 

CSBG State Plan format for states and 

territories by revising questions for 

clarity and system compatibility. OCS 

does not anticipate that these revisions 

will cause any additional burden to 

CSBG grantees as they have completed 

the automated plan for six years. It is 

anticipated that the burden will 

continue to diminish in subsequent 

years due to improved automation. 

In addition to the CSBG State Plan, 

OCS requests that all grantees revise 

their CSBG Eligible Entity Master List in 

year one to add the executive director 

and website for each agency. Grantees 

will revise the Master List as necessary 

in subsequent years. As the CSBG 

Eligible Entity Master List is already 

completed and states have the 

information about their eligible entities 

(or sub-grantees), the burden will be 

minimal to the states to provide the 

additional requested information. 

Lastly, the request includes a survey 

for the sub-grantees (or CSBG-eligible 

entities). The survey focuses on the 

customer service that the CSBG subgrantees receive from the CSBG 

grantees. The survey is optional, and 

this will be the fifth time that the CSBG 

sub-grantees that chose to submit will 

complete it. There are no revisions 

proposed to the survey. 

Respondents: State governments, 

including the District of Columbia and 

the Commonwealth of Puerto Rico, and 

U.S. territories, and local level subgrantees. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

CSBG State Plan Application for States ............................. 56 3 31 5,208 1,736 

CSBG Eligible Entity Master List ......................................... 56 3 2 336 112 

CSBG ACSI Survey of Eligible Entities ............................... 1,007 1 .33 332 111 

Estimated Total Annual Burden 

Hours: 1,848 hours for CSBG grantees; 

111 for CSBG sub-grantees. 

Authority: Sec. 676, Pub. L. 105–285, 112 

Stat. 2735 (42 U.S.C. 9908) 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–13742 Filed 6–25–21; 8:45 am] 

BILLING CODE 4184–27–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–E–1328] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Smallpox and Monkeypox 

Vaccine, Live 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Smallpox and Monkeypox Vaccine, 

Live and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 34019 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 27, 2021. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 27, 2021. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 27, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 27, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2020–E–1328 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; Smallpox and 

Monkeypox Vaccine, Live.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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 § 10.20 (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: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

product. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of USPTO may award 

(for example, half the testing phase must 

be subtracted as well as any time that 

may have occurred before the patent 

was issued), FDA’s determination of the 

length of a regulatory review period for 

a human biological product will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA has approved for marketing the 

human biologic product Smallpox and 

Monkeypox Vaccine, Live (Modified 

Vaccinia Ankara). Smallpox and 

Monkeypox Vaccine, Live, is indicated 

for prevention of smallpox and 

monkeypox disease in adults 18 years of 

age and older determined to be at high 

risk for smallpox or monkeypox 

infection. Subsequent to this approval, 

the USPTO received a patent term 

restoration application for Smallpox and 

Monkeypox Vaccine, Live (U.S. Patent 

No. 7,335,364) from Bavarian Nordic 

A/S, and the USPTO requested FDA’s 


khammond on DSKJM1Z7X2PROD with NOTICES
34020 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated July 14, 2020, FDA 

advised the USPTO that this human 

biological product had undergone a 

regulatory review period and that the 

approval of Smallpox and Monkeypox 

Vaccine, Live represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

Smallpox and Monkeypox Vaccine, Live 

is 5,650 days. Of this time, 5,315 days 

occurred during the testing phase of the 

regulatory review period, while 335 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective: April 7, 2004. The 

applicant claims March 8, 2004, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was April 7, 2004, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): October 25, 2018. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

Smallpox and Monkeypox Vaccine, Live 

(BLA 125678) was initially submitted on 

October 25, 2018. 

3. The date the application was 

approved: September 24, 2019. FDA has 

verified the applicant’s claim that BLA 

125678 was approved on September 24, 

2019. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,825 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13686 Filed 6–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2099] 

Sponsor Responsibilities—Safety 

Reporting Requirements and Safety 

Assessment for Investigational New 

Drug Application and Bioavailability/ 

Bioequivalence Studies; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Sponsor 

Responsibilities—Safety Reporting 

Requirements and Safety Assessment for 

Investigational New Drug Application 

and Bioavailability/Bioequivalence 

Studies.’’ The draft guidance provides 

recommendations for sponsors and 

sponsor-investigators to comply with 

the requirements of investigational new 

drug application (IND) safety reporting 

and safety reporting for bioavailability 

(BA) and bioequivalence (BE) studies. In 

doing so, the guidance provides 

recommendations related to the two IND 

safety reporting provisions that require 

assessment of aggregate data to facilitate 

appropriate IND safety reporting 

practices. An earlier draft guidance for 

industry entitled ‘‘Safety Assessment for 

IND Safety Reporting’’ (December 2015) 

(the 2015 draft guidance) has been 

incorporated into this draft guidance. 

However, this content was revised to 

address feedback from stakeholders and 

comments received on the 2015 draft 

guidance. Concurrent with the 

publication of this draft guidance, we 

are withdrawing the 2015 draft 

guidance. Additionally, this draft 

guidance incorporates content from the 

final guidance for industry and 

investigators entitled ‘‘Safety Reporting 

Requirements for INDs and BA/BE 

Studies’’ (December 2012) (the 2012 

final guidance). This incorporated 

content remains largely unchanged in 

this draft guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 27, 2021 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 


khammond on DSKJM1Z7X2PROD with NOTICES